PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 6, 2017 Initiated: July 12, 2017 #Z-3076-2017

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.

Details

Recalling Firm
Biomerieux Inc
Units Affected
9234 units
Distribution
Worldwide
Location
Hazelwood, MO

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomerieux Inc. Units affected: 9234 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-3076-2017.