Cl ll bioMerieux BacT/ALERT 3D 60

Company: BioMerieux Inc.
Date of Enforcement Report 11/28/12
Class ll:

PRODUCT

bioMerieux BacT/ALERT 3D 60, catalog number, 248009, 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-0301-2013

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
145 modules

DISTRIBUTION
Nationwide and Internationally

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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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Partners located in the US (CA, FL, MA, MN) and Italy.