Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
FDA Recall Z-1247-06 · 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 Quantity5 mL: 3870; 20 mL: 29,007 (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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