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Advia Centaur CP and XP System-B-type Natriuretic Peptide (BNP) assay and Advia Centaur System-B-type Natriuretic Peptide (BNP) assay (2014-10-08)
- Starting date:
- October 8, 2014
- Posting date:
- October 22, 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-41865
Recalled Products
A) Advia Centaur CP System-B-type Natriuretic Peptide (BNP) assay
B) Advia Centaur XP System-B-type Natriuretic Peptide (BNP) assay
C) Advia Centaur System-B-type Natriuretic Peptide (BNP) assay
Reason
There may be an incorrect side label on a small percentage of the Advia Centaur Systems BNP ready packs from reagent lot 038174. Incorrectly labeled ready packs are included within kit lots 43305174, 43278174, 43306174 and 43279174. The human-readable side label may incorrectly identify the ready pack as Advia Centaur Systems FT4 ready pack. The ready pack end label and the barcode end label correctly identify the ready pack as the Advia Centaur Systems BNP ready pack and the ready pack will scan correctly as BNP when loaded onto the Advia Centaur Systems. The kit boxes are correctly labeled as BNP. Other Advia Centaur BNP kit lots ending in 174 are not impacted.
Affected products
A) Advia Centaur CP System-B-type Natriuretic Peptide (BNP) assay
Lot or serial number
43278174
43279174
43305174
43306174
Model or catalog number
02816138
02816634
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B) Advia Centaur XP System-B-type Natriuretic Peptide (BNP) assay
Lot or serial number
43278174
43279174
43305174
43306174
Model or catalog number
02816138
02816634
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C) Advia Centaur System-B-type Natriuretic Peptide (BNP) assay
Lot or serial number
43278174
43279174
43305174
43306174
Model or catalog number
02816138
02816634
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES