BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are pres
FDA device recall Z-2244-2011 · posted 2011-05-24 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- The charcoal suspension in a portion of the lot does not meet the intended density.
- Action taken
- BioMerieux sent an Urgent Product Removal Notice dated April 13, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Evaluate positive results adhering to their institution's protocols for determining false versus true positives. Negative bottles should be checked by smear and/or subculture at some point prior to discarding as negative. Any remaining inventory of BacT/ALERT FA culture bottle lot 1027481 should be destroyed in accordance with their facility's policies and procedures. An Acknowledgement and Product Replacement Form was included to be completed and returned to bioMerieux or credit or replacement of unused bottles.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 327,700 bottles
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium
- Date initiated
- 2011-04-13
- Date posted
- 2011-05-24
- Date terminated
- 2012-04-03
- 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 FA CULTURE BOTTLE (K020813) | bioMerieux, Inc. | 2002-04-17 |