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U.S. Department of Health and Human Services

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 Class 2 Recall
BacT/ALERT SA Blood Culture Bottle		see related information
Date Posted January 25, 2013
Recall Number Z-0738-2013
Product BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Code Information Catalog Number: 259789, Lots/Batch: 1031866
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham, North Carolina 27712-9402
For Additional Information Contact Ryan LeMelle
919-620-2599
Reason for
Recall		 BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Action bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" and Acknowledgement Form on January 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local bioMerieux Customer Service Representative for additional assistance.
Quantity in Commerce 1690 cases
Distribution Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
 
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