Company:Biomerieux Inc .
Date of Enforcement Report 4/3/2013
Class ll:
PRODUCT
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Recall Number Z-0989-2013
REASON
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
RECALLING FIRM/MANUFACTURER
Biomerieux Inc., Hazelwood, MO, on 2/18/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed
DISTRIBUTION
Nationwide and Internationally
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