BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Dur
FDA device recall Z-0644-2007 · posted 2007-03-22 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Bottle data is not sent to BacT/ALERT 3D instrument.
- Action taken
- A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 1233 disks
- Distribution
- Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
- Date initiated
- 2006-12-19
- 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 3D MICROBIAL DETECTION SYSTEM (K981736) | Organon Teknika Corp. | 1998-07-24 |
| MB/BACT MYCROBACTERIA DETECTION SYSTEM (K954468) | Organon Teknika Corp. | 1996-07-22 |
| BACT/ALERT 120 (K934593) | Organon Teknika Corp. | 1994-02-09 |
| BACT/ALERT (TM) (K903505) | Organon Teknika Corp. | 1991-03-12 |