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Health product recall

Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - II (2014-10-10)

Starting date:
October 10, 2014
Posting date:
November 24, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-42131

Reason

Multiple customer complaints of leaking dimension flexes while inside the flex wrapper. There has been a recent increase of complaints starting in April 2014 citing lidstock cuts and loose lidstock (delamination) resulting in the leaking flexes. There may be a single leaking flex or multiple leaking flexes from a carton as well as leaks in multiple cartons.

Recalled Products

  1. Dimension Clinical Chemistry System-ALP/Alkaline Phosphatase
  2. Dimension Clinical Chemistry System -Revised Amylase
  3. Dimension Chemistry System - Troponin I
  4. Dimension Clinical Chemistry System -ALB/Albumin
  5. Dimension Clinical Chemistry System -Total Iron Binding Capacity (TIBC)
  6. Dimension Clinical Chemistry System -Complement C3 Flex Reagent
  7. Dimension Clinical Chemistry System -Transferrin Reagent Cartridge
  8. imension Clinical Chemistry System-Enzymatic Carbonate Flex Reagent
  9. Dimension Clinical Chemistry System -lithium flex reagent cartridge
  10. Dimension Xpand System-Enzymatic Carbonate Flex Reagent
  11. Dimension Xpand System-Human Chorionic Gonadotropin Flex (IHCG)
  12. Dimension Xpand System-ITNI Cardiac Troponin I Flex Reagent
  13. Dimension xpand system-Immb Mass Creatine Kinase MB Isoenzyme Flex Assay
  14. Dimension Chemistry System -(FPSA) Free Prostate Ppecific Antigen Flex Reagent
  15. Dimension Chemistry System -(TPSA) Total Prostate Specific Antigen Flex Reagent
  16. Dimension Clinical Chemistry System -LDL Choloesterol Flex Reagent Cart. (ALDL)
  17. Dimension Clinical Chemistry System -Glucose Flex Reagent Cartridge (Gluc)
  18. Dimension Clinical Chemistry System -Urine Amphet./Methamphet. Screen Flex
  19. Dimension Clinical Chemistry System-Microalbumin Flex Reagent Cartridge (MALB)
  20. Dimension EXL System-Cardiac Troponin-I(CTNI) Assay
  21. Dimension EXL System -Free PSA (FPSA) Assay
  22. Dimension EXL System -Mass Creatine Kinase MB Isoenzyme (MMB) Assay
  23. Dimension EXL System -Myoglobin (MYO) Assay
  24. Dimension EXL System - N-terminal Pro-Brain Natriuretic Peptide (PBNP) assay
  25. Dimension EXL System -Tacrolimus (TACR) Assay
  26. Dimension EXL System -Total PSA (TPSA) assay
  27. Dimension EXL System - Creatine Kinase Flex (CKI) assay
  28. Dimension EXL System - Lactate Dehydrogenate (LDI) Assay
  29. Dimension XP and System- Creatine Kinase Flex (CKI) assay
  30. Dimension XP and System - Lactate Dehydrogenate Flex (LDI)
  31. Dimension Clinical Chemistry System-Creatine Kinase Flex (CKI) assay
  32. Dimension Clinical Chemistry System -Lactate Dehydrogenate Flex (LDI)
  33. Dimension Clinical Chemistry System.- automated HDL cholesterol (AHDL) assay
  34. Dimension XP and System-automated HDL cholesterol (AHDL) assay
  35. Dimension EXL System-automated HDL cholesterol (AHDL) Assay
  36. Dimension Chemistry Ssystem-Creatine Kinase MB (MBI) Assay
  37. Dimension XPL and System-Creatine Kinase MB (MBI) Assay
  38. Dimension EX  Lsyste,- Creatine Kinase MB (MBI) Assay
  39. Dimension XP and System-Total Iron Binding Capacity (IBCT) Asay
  40. Dimension EXL System- Total Iron Binding Capacity (IBCT) Asay
  41. Dimension XP and System-Acetominophen (ACTM) assay
  42. Dimension XP and System-Albumin (ALB) Assay
  43. Dimension XP and  system-Ethyl Alcohol (ACL) Assay
  44. Dimension XP and  System -Automated LDL (ALDL) Cholesterol assay
  45. Dimension XP and  System -Alanine Aminotransferase (ALT) Assay
  46. Dimension XP and  System -Ammonia (AMON) Assay
  47. Dimension XP and  Aystem -Urine Amphetamine/Methamphetamine (AMPH)
  48. Dimension XP and  System -Amylase (AMY) Assay
  49. Dimension XP and  System -Aspartate Aminotranspherase (AST) Assay
  50. Dimension XP and  System -Urine Bariturate (BARB) Screen
  51. Dimension XP and  System -Urine Benzodiazepines (BENZ) Screen
  52. Dimension XP and  System -Urea Nitrogen (BUN) Assay
  53. Dimension XP and  System -Complement C3 Assay
  54. Dimension XP and  System -Complement C4 Assay
  55. Dimension XP and System-Calcium (Ca) Assay
  56. Dimension XP and System -Cardio Phase High Sensitivity CRP (CCRP)
  57. Dimension XP and System -Cholesterol (CHOL) Assay
  58. Dimension XP and System -Urine Cocaine (COC) Metabolite Screen
  59. Dimension XP and System -Carbamazapine (CRBM) Assay
  60. Dimension XP and System -Creatinine (CREA) Assay

Affected products

1) Dimension Clinical Chemistry System-ALP/Alkaline Phosphatase

Lot or serial number

Not applicable

Model or catalog number

  • DF15A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


2) Dimension Clinical Chemistry System -Revised Amylase

Lot or serial number

Not applicable

Model or catalog number

  • DF17A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


3) Dimension Chemistry System - Troponin I

Lot or serial number

Not applicable

Model or catalog number

  • DF73

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


4) Dimension Clinical Chemistry System -ALB/Albumin

Lot or serial number

Not applicable

Model or catalog number

  • DF13

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


5) Dimension Clinical Chemistry System -Total Iron Binding Capacity (TIBC)

Lot or serial number

Not applicable

Model or catalog number

  • 10444944 and
  • DF84

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


6) Dimension Clinical Chemistry System -Complement C3 Flex Reagent

Lot or serial number

Not applicable

Model or catalog number

  • DF101 and
  • DF102

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


7) Dimension Clinical Chemistry System -Transferrin Reagent Cartridge

Lot or serial number

Not applicable

Model or catalog number

  • DF103

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


8) imension Clinical Chemistry System-Enzymatic Carbonate Flex Reagent

Lot or serial number

Not applicable

Model or catalog number

  • 10444975 and
  • DF137

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


9) Dimension Clinical Chemistry System -lithium flex reagent cartridge

Lot or serial number

Not applicable

Model or catalog number

  • DF132

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


10) Dimension Xpand System-Enzymatic Carbonate Flex Reagent

Lot or serial number

Not applicable

Model or catalog number

  • 10444972 and
  • DF137

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


11) Dimension Xpand System-Human Chorionic Gonadotropin Flex (IHCG)

Lot or serial number

Not applicable

Model or catalog number

  • RF530

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


12) Dimension Xpand System-ITNI Cardiac Troponin I Flex Reagent

Lot or serial number

Not applicable

Model or catalog number

  • 10444905,
  • RF421C and
  • RF521

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


13) Dimension xpand system-Immb Mass Creatine Kinase MB Isoenzyme Flex Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444904 and
  • RF520

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


14) Dimension Chemistry System -(FPSA) Free Prostate Ppecific Antigen Flex Reagent

Lot or serial number

Not applicable

Model or catalog number

  • RF452

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


15) Dimension Chemistry System -(TPSA) Total Prostate Specific Antigen Flex Reagent

Lot or serial number

Not applicable

Model or catalog number

  • RF451

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


16) Dimension Clinical Chemistry System -LDL Choloesterol Flex Reagent Cart. (ALDL)

Lot or serial number

Not applicable

Model or catalog number

  • DF131

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


17) Dimension Clinical Chemistry System -Glucose Flex Reagent Cartridge (Gluc)

Lot or serial number

Not applicable

Model or catalog number

  • DF40

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


18) Dimension Clinical Chemistry System -Urine Amphet./Methamphet. Screen Flex

Lot or serial number

Not applicable

Model or catalog number

  • DF91B

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


19) Dimension Clinical Chemistry System-Microalbumin Flex Reagent Cartridge (MALB)

Lot or serial number

Not applicable

Model or catalog number

  • 10444896,
  • 10444905,
  • RF421C and
  • RF521

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


20) Dimension EXL System-Cardiac Troponin-I(CTNI) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444896,
  • 10444905,
  • RF421C and
  • RF521

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


21) Dimension EXL System -Free PSA (FPSA) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444888 and
  • RF452

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


22) Dimension EXL System -Mass Creatine Kinase MB Isoenzyme (MMB) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444895,
  • 10444904,
  • RF420 and
  • RF520

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


23) Dimension EXL System -Myoglobin (MYO) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444907
  • RF422A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


24) Dimension EXL System - N-terminal Pro-Brain Natriuretic Peptide (PBNP) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444901
  • RF423A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


25) Dimension EXL System -Tacrolimus (TACR) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444938
  • DF107

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


26) Dimension EXL System -Total PSA (TPSA) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444889
  • RF451

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


27) Dimension EXL System - Creatine Kinase Flex (CKI) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464511
  • DF38

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


28) Dimension EXL System - Lactate Dehydrogenate (LDI) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10284483
  • DF54

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


29) Dimension XP and System- Creatine Kinase Flex (CKI) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464511
  • DF38

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


30) Dimension XP and System - Lactate Dehydrogenate Flex (LDI)

Lot or serial number

Not applicable

Model or catalog number

  • 10284483
  • DF54

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


31) Dimension Clinical Chemistry System-Creatine Kinase Flex (CKI) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464511 and
  • DF38

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


32) Dimension Clinical Chemistry System -Lactate Dehydrogenate Flex (LDI)

Lot or serial number

Not applicable

Model or catalog number

  • 10284483
  • DF54

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


33) Dimension Clinical Chemistry System.- automated HDL cholesterol (AHDL) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464332
  • DF48B

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


34) Dimension XP and System-automated HDL cholesterol (AHDL) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464332
  • DF48B

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


35) Dimension EXL System-automated HDL cholesterol (AHDL) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464332
  • DF48B

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


36) Dimension Chemistry Ssystem-Creatine Kinase MB (MBI) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464510
  • DF32

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


37) Dimension XPL and System-Creatine Kinase MB (MBI) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464510
  • DF32

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


38) Dimension EX  Lsyste,- Creatine Kinase MB (MBI) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10464510
  • DF32

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


39) Dimension XP and System-Total Iron Binding Capacity (IBCT) Asay

Lot or serial number

Not applicable

Model or catalog number

  • 10444944
  • DF84

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


40) Dimension EXL System- Total Iron Binding Capacity (IBCT) Asay

Lot or serial number

Not applicable

Model or catalog number

  • 10444944
  • DF84

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


41) Dimension XP and System-Acetominophen (ACTM) assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444916
  • DF88

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


42) Dimension XP and System-Albumin (ALB) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444975
  • DF13

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


43) Dimension XP and  system-Ethyl Alcohol (ACL) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444917
  • DF18

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


44) Dimension XP and  System -Automated LDL (ALDL) Cholesterol assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444890
  • DF131

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


45) Dimension XP and  System -Alanine Aminotransferase (ALT) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444958
  • 10475530
  • DF143
  • DF43A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


46) Dimension XP and  System -Ammonia (AMON) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444954
  • DF19

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


47) Dimension XP and System -Urine Amphetamine/Methamphetamine (AMPH)

Lot or serial number

Not applicable

Model or catalog number

  • 10444926
  • DF91B

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


48) Dimension XP and  System -Amylase (AMY) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444965
  • DF17A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


49) Dimension XP and  System -Aspartate Aminotranspherase (AST) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444959
  • DF41A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


50) Dimension XP and  System -Urine Bariturate (BARB) Screen

Lot or serial number

Not applicable

Model or catalog number

  • 10444918
  • DF96A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


51) Dimension XP and  System -Urine Benzodiazepines (BENZ) Screen

Lot or serial number

Not applicable

Model or catalog number

  • 10444919
  • DF97A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


52) Dimension XP and  System -Urea Nitrogen (BUN) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444969
  • DF21

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


53) Dimension XP and  System -Complement C3 Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444981
  • DF101

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


54) Dimension XP and  System -Complement C4 Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444981
  • DF102

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


55) Dimension XP and System-Calcium (Ca) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444949
  • DF23A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


56) Dimension XP and System -Cardio Phase High Sensitivity CRP (CCRP)

Lot or serial number

Not applicable

Model or catalog number

  • 10444897
  • RF434

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


57) Dimension XP and System -Cholesterol (CHOL) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444891
  • DF27

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


58) Dimension XP and System -Urine Cocaine (COC) Metabolite Screen

Lot or serial number

Not applicable

Model or catalog number

  • 10444920
  • DF92A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


59) Dimension XP and System -Carbamazapine (CRBM) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444930
  • DF87

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


60) Dimension XP and System -Creatinine (CREA) Assay

Lot or serial number

Not applicable

Model or catalog number

  • 10444968
  • DF33A

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


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