FDAFDA · Food and drugs·Recall number Z-3076-2017
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.
Published September 6, 2017 · Recall initiated: July 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- Worldwide
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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