Recall Z-0738-2013 ยท MDB System, Blood Culturing
bioMerieux, Inc.
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.
| Date | Jan 25, 2013 (initiated Dec 25, 2012) |
| Status | Terminated |
| Reason | BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. |
| Root cause | Nonconforming Material/Component |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020931 | BACT/ALERT SA CULTURE BOTTLE bioMerieux, Inc., Apr 18, 2002 |