Coagulation Analyzers (Instrumentation Laboratory) – PT Reporting Error (2005)
Coagulation analyzer may report low prothrombin time for patients on anticoagulant therapy.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354
Products Sold
Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354
Instrumentation Laboratory Co. is recalling ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin rea due to Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026