Devices

Device Recall HemosIL RecombiPlasTin

Model / Serial
Product No.0020002900 (8mL): Lots N0649021, N0253072, N0253739, N1150411; Part No. 0020003000 (20 mL): Lots N0347531, N0447950, N0740293, N1040969, N1141498, N0152736, N0453415, N0454252, N0756711, N0958473, N1150445, N1250485, N1250619, N0160792.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
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.
Manufacturer
Instrumentation Laboratory Co.
1 Event
- Recall of Device Recall HemosIL RecombiPlasTin

Manufacturer

Instrumentation Laboratory Co.

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

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