Recall Z-0776-2007 ยท MDB System, Blood Culturing
bioMerieux, Inc.
BacT/ALERT 3D 60 Systems Software, Blood Culturing System
| Date | May 3, 2007 (initiated Aug 14, 2006) |
| Status | Terminated |
| Reason | Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems. |
| Root cause | Other |
| Action | Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006. |
| Quantity | 10790 units, total for all models |
| Distribution | Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981736 | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM Organon Teknika Corp., Jul 24, 1998 |