Recall Z-0738-2013
bioMerieux, Inc. · initiated December 25, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: 259789, Lots/Batch: 1031866
Reason for recall
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0738-2013
- Initiated
- December 25, 2012
- Posted by FDA
- January 25, 2013
- Terminated
- June 3, 2014
- Product code
- MDB – System, Blood Culturing
- Quantity
- 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.
- Recalling firm
- bioMerieux, Inc., Durham, NC