BacT/ALERT 3D System Software, Blood Culturing System
FDA device recall Z-0774-2007 · posted 2007-05-03 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- Action taken
- Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 10790 units, total for all models
- Distribution
- Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe
- Date initiated
- 2006-08-14
- Date posted
- 2007-05-03
- 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 120 (K934593) | Organon Teknika Corp. | 1994-02-09 |