Instrumentation Laboratory Co.

Serial numbers prior to 07060782

Hematology and Pathology Devices

2

No

Nationwide.

Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. || P/N 280000

Serial numbers prior to 07020343 with Software versions prior to V1.1.3

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden

GEM Premier 4000 Laboratory Analyzer

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.

Hematology and Pathology Devices

2

No

Nationwide

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.

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.

Hematology and Pathology Devices

2

No

Nationwide

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.

Serial numbers starting with 18412

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Foreign: Canada

GEM PREMIER 3000