Recall Z-0043-05 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
bioMerieux
The MDA system with MDA Antithrombin III MDA Heparin
| Date | Oct 23, 2004 (initiated Jun 11, 2004) |
| Status | Terminated |
| Reason | The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens. |
| Root cause | Other |
| Action | Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004. |
| Distribution | Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.