Recall Z-0243-2007 ยท MDB System, Blood Culturing
bioMerieux, Inc.
bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
| Date | Dec 5, 2006 (initiated Aug 17, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021123 | BACT/ALERT SN CULTURE BOTTLE bioMerieux, Inc., Apr 26, 2002 |