bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
FDA device recall Z-0243-2007 · posted 2006-12-05 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
- Action taken
- Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 34,440
- Distribution
- Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.
- Date initiated
- 2006-08-17
- Date posted
- 2006-12-05
- 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 SN CULTURE BOTTLE (K021123) | bioMerieux, Inc. | 2002-04-26 |