Instrumentation Laboratory Co. recalls Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 -
Recalled Product
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Hazard / Issue
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Issued by
FDA
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