Instrumentation Laboratory Co.

Software prior to Version V3.5

Hematology and Pathology Devices

2

No

Florida Canada

ACL Futura Instrument Analyzer

Software version prior to V2.1

Hematology and Pathology Devices

2

No

Florida Canada

ACL Advance Instrument Analyzer

Models:  290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354

Hematology and Pathology Devices

2

No

Nationwide Canada

ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent

Serial numbers starting with 18412

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Foreign: Canada

GEM PREMIER 3000

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.