BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
FDA device recall Z-0643-2007 · posted 2007-03-22 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
- Action taken
- Consignees were notified by letter on/about 01/12/2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 2136 cases (100 bottles per case)
- Distribution
- Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.
- Date initiated
- 2007-01-11
- Date posted
- 2007-03-22
- 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 FA CULTURE BOTTLE (K020813) | bioMerieux, Inc. | 2002-04-17 |