VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Reported: September 6, 2017 Initiated: July 12, 2017 #Z-3075-2017
Product Description
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R 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.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 1866 units
- Distribution
- Worldwide
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.. Recalled by Biomerieux Inc. Units affected: 1866 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Moderate. Recall number: Z-3075-2017.
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