BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microo
FDA device recall Z-0738-2013 · posted 2013-01-25 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 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, C
- Date initiated
- 2012-12-25
- Date posted
- 2013-01-25
- Date terminated
- 2014-06-03
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACT/ALERT SA CULTURE BOTTLE (K020931) | bioMerieux, Inc. | 2002-04-18 |