Devices

Device Recall Hemoliance RecombiPlasTin

Model / Serial
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.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
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.
Manufacturer
Instrumentation Laboratory Co.
1 Event
- Recall of Device Recall Hemoliance RecombiPlasTin

Manufacturer

Instrumentation Laboratory Co.

Manufacturer Address
Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
Source
USFDA

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