Company: bioMerieux Inc.
Date of Enforcement Report: 8/14/2013
Class ll:

PRODUCT

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Recall Numbers Z-1907-2013, Z-1908-2013, Z-1909-2013, Z-1910-2013, Z-1911-2013, Z-1912-2013, Z-1913-2013, Z-1914-2013, Z-1915-2013, Z-1916-2013,Z-1917-2013,Z-1918-2013,Z-1919-2013,Z-1920-2013,Z-1921-2013

REASON
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.

RECALLING FIRM/MANUFACTURER
bioMerieux Inc., Hazelwood, MO on 6/14/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12,384 total kits

DISTRIBUTION
Nationwide and Internationally

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