Recall Z-0915-05 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Instrumentation Laboratory Co.
ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
| Date | Jun 21, 2005 (initiated May 19, 2005) |
| Status | Terminated |
| Reason | Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy |
| Root cause | Other |
| Action | Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005. |
| Quantity | 617 units |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |