Company: BioMerieux Inc.
Date of Enforcement Report 11/28/12
Class ll:
PRODUCT
1. bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which 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-0311-2013 205 kits
2. bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Recall Number Z-0312-2013 205 kits
3. bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Recall Number Z-0313-2013 250 kits
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
see product information above
DISTRIBUTION
Nationwide and Internationally
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