Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in
Recalled Product
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Hazard / Issue
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
Issued by
FDA
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