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MicroScan's Microorganism Confirmation Panel (2014-08-14)
- Starting date:
- August 14, 2014
- Posting date:
- August 25, 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-41195
Recalled Products
- MicroScan Neg/Urine MIC Panel
- MicroScan Neg/Urine-Combo Panel
- MicroScan Neg BP Combo Panel
- MicroScan ESBL Plus Confirmation Panel
Reason
A technical support bulletin (TSB-190) provided instructions for creating new lab pro AST interpretation action alert rules to enable reporting of the new Enterobacteriaceae breakpoints on MicroScan dried Gram Negative MIC/Combo panel types containing the lower imipenem (Imp) dilutions. However, the TSB did not mention the performance limitation for the Enterobacteria Proteus mirabilis and imipenem, for which the revised interpretive criteria may result in minor errors with clinical P. mirabilis isolates. Therefore, the drug name, Minimal Inhibitory Concentration (MIC) and interpretation should not be reported for P. Mirabilis and imipenem on the MicroScan dried Gram Negative MIC/Combo panels listed in (1).
Affected products
A. MicroScan Neg/Urine MIC Panel
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
B1017-412
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
2040 Enterprise Blvd. West
Sacramento
95691
California
UNITED STATES
B. MicroScan Neg/Urine-Combo Panel
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- B1017-407
- B1017-409
- B1017-414
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
2040 Enterprise Blvd. West
Sacramento
95691
California
UNITED STATES
C. MicroScan Neg BP Combo Panel
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
B1017-417
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
2040 Enterprise Blvd. West
Sacramento
95691
California
UNITED STATES
D. MicroScan ESBL Plus Confirmation Panel
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
B1027-101
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
2040 Enterprise Blvd. West
Sacramento
95691
California
UNITED STATES