BacT/ALERT(BTA) Classic instruments.
FDA device recall Z-0456-05 · posted 2005-02-01 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- Over heating of memory board.
- Action taken
- Consignees were notified by letter on September 17, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 1626 units
- Distribution
- Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portuga
- Date initiated
- 2004-09-17
- Date posted
- 2005-02-01
- 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 (TM) (K903505) | Organon Teknika Corp. | 1991-03-12 |