ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
FDA Recall Z-0915-05 · Posted 2005-06-21
Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeJPA
Date Initiated2005-05-19
Date Terminated2006-12-06
Product Quantity617 units
Reason for Recall
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.