BacT/ALERT FN Culture Bottles, Product Number 259793
FDA device recall Z-1189-2007 · posted 2007-08-22 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.
- Action taken
- Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.
- Root cause
- Other
- Status
- Terminated
- Product code
- MBD
- Quantity affected
- 2,403 cases (100 bottles per case)
- Distribution
- Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanat
- Date initiated
- 2007-02-16
- Date posted
- 2007-08-22
- Date terminated
- 2009-12-08
- 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 FN (K992432) | Organon Teknika Corp. | 1999-09-24 |