Recall Z-0613-05 ยท MDB System, Blood Culturing
BIOMERIEUX, INC.
Bac T/ALERT 3D Combination Module
| Date | Sep 7, 2005 (initiated May 27, 2005) |
| Status | Terminated |
| Reason | A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle. |
| Root cause | Other |
| Action | Consignees were notified by letter on May 27, 2005. |
| Quantity | 2,001 units |
| Distribution | Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903505 | BACT/ALERT (TM) Organon Teknika Corp., Mar 12, 1991 |