ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
This recall has been terminated (originally issued June 21, 2005).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- May 19, 2005
- Posted
- June 21, 2005
- Terminated
- December 6, 2006
- Recall Number
- Z-0915-05
- Quantity
- 617 units
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
Distribution
Nationwide Canada
Lot / Code Info
Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354
Root Cause
Other
Action Taken
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.
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