Company: BioMerieux Inc.
Date of Enforcement Report 11/28/12
Class ll:
PRODUCT
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Recall Number Z-0299-2013
REASON
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
RECALLING FIRM/MANUFACTURER
Biomerieux Inc., Hazelwood, MO on 10/16/2012 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
70 modules
DISTRIBUTION
Nationwide and Internationally
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