Bac T/ALERT 3D Combination Module
FDA device recall Z-0613-05 · posted 2005-09-07 · Terminated
Recall details
- Recalling firm
- BIOMERIEUX, INC.
- Reason for recall
- A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
- Action taken
- Consignees were notified by letter on May 27, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 2,001 units
- Distribution
- Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Me
- Date initiated
- 2005-05-27
- Date posted
- 2005-09-07
- Date terminated
- 2006-09-21
- 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 |