HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
FDA Recall Z-1246-06 · Posted 2006-07-18
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Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGJS
Date Initiated2006-03-07
Date Terminated2006-08-11
Product Quantity8 mL: 10,473; 20 mL: 5110 (all Domestic)
Reason for Recall
Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).
Firm Action
"Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
Root Cause
Other
Distribution Pattern
Nationwide
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.
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