VITEK 2 Test Cards (2019-01-14)
- Starting date:
- January 14, 2019
- Posting date:
- February 15, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69030
Affected Products
- A. VITEK 2 Compact 30 System - susceptibility test cards
- B. VITEK 2 Compact 60 System - susceptibility test cards
- C. VITEK 2 System - susceptibility test cards
- D. VITEK 2 ANC ID
- E. VITEK 2 GN Card
Reason
A potential issue was identified related to the top seal of card pouches containing the VITEK 2 test cards. BioMérieux has determined that the integrity of some of the VITEK 2 test card top seal may be compromised. A compromised test card top seal can impact card reagents due to the entry of moisture. BioMérieux investigation concluded that the pouch top seal of the card lots manufactured on a specific card poucher (poucher 1) between 10 Aug. 2018 and 29 Aug. 2018 is potentially compromised.
Affected products
A. VITEK 2 Compact 30 System - susceptibility test cards
Lot or serial number
6260813203
Model or catalog number
413 143
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham, North Carolina
27712
UNITED STATES
B. VITEK 2 Compact 60 System - susceptibility test cards
Lot or serial number
2750809103
2750823203
Model or catalog number
415 670
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham, North Carolina
27712
UNITED STATES
C. VITEK 2 System - susceptibility test cards
Lot or serial number
2880809203
5420809203
5420812203
Model or catalog number
420 739
421 040
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham, North Carolina
27712
UNITED STATES
D. VITEK 2 ANC ID
Lot or serial number
2440811203
Model or catalog number
21347
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham, North Carolina
27712
UNITED STATES
E. VITEK 2 GN Card
Lot or serial number
2410602403
2410632203
2410636203
Model or catalog number
21341
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham, North Carolina
27712
UNITED STATES