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.
This recall has been terminated (originally issued July 18, 2006).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- March 7, 2006
- Posted
- July 18, 2006
- Terminated
- August 11, 2006
- Recall Number
- Z-1247-06
- Quantity
- 5 mL: 3870; 20 mL: 29,007 (all Domestic)
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide
Lot / Code Info
Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152; Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.
Root Cause
Other
Action Taken
"Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
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