Recall Z-0643-2007 ยท MDB System, Blood Culturing
bioMerieux, Inc.
BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
| Date | Mar 22, 2007 (initiated Jan 11, 2007) |
| Status | Terminated |
| Reason | Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about 01/12/2007. |
| Quantity | 2136 cases (100 bottles per case) |
| Distribution | Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020813 | BACT/ALERT FA CULTURE BOTTLE bioMerieux, Inc., Apr 17, 2002 |