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.
This recall has been terminated (originally issued January 25, 2013).
- Company
- Biomerieux, Inc.
- Recall Initiated
- December 25, 2012
- Posted
- January 25, 2013
- Terminated
- June 3, 2014
- Recall Number
- Z-0738-2013
- Quantity
- 1690 cases
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
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.
Lot / Code Info
Catalog Number: 259789, Lots/Batch: 1031866
Root 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.