medical Class II Updated 2021-12-01

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

Distribution: Nationwide (United States)
Lot/Code Info: Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
View official government recall

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