Recall Z-2244-2011 ยท MDB System, Blood Culturing
bioMerieux, Inc.
BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions
| Date | May 24, 2011 (initiated Apr 13, 2011) |
| Status | Terminated |
| Reason | The charcoal suspension in a portion of the lot does not meet the intended density. |
| Root cause | Other |
| Action | BioMerieux sent an Urgent Product Removal Notice dated April 13, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Evaluate positive results adhering to their institution's protocols for determining false versus true positives. Negative bottles should be checked by smear and/or subculture at some point prior to discarding as negative. Any remaining inventory of BacT/ALERT FA culture bottle lot 1027481 should be destroyed in accordance with their facility's policies and procedures. An A |
| Quantity | 327,700 bottles |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020813 | BACT/ALERT FA CULTURE BOTTLE bioMerieux, Inc., Apr 17, 2002 |