Z-3076-2017 Class II Terminated
FDA device recall Z-3076-2017 was initiated by Biomerieux Inc on July 12, 2017 and is designated Class II. Reason for recall: Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be process… The recall status is terminated (terminated December 16, 2020). Affected quantity: 9234 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- July 12, 2017
- Termination Date
- December 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9234 units
Product Description
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Reason for Recall
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Distribution Pattern
Worldwide
Code Information
VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.