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Recall Observatory FDA recall evidence

Device product

HemosIL ReadiPlasTin, Part No. 0020301400

Z-1052-2022

April 08, 2022

Class II

Product summary

Firm
Instrumentation Laboratory
Event
Event 90012
Status
Ongoing
Classification
Class II
Quantity
1,563 (US); 29,046 (OUS)
Official record key
device-enforcement:Z-1052-2022

Official wording

Reason: Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

Code information: UDI 08426950632887 All in-date lots are affected by this recall.

Distribution pattern: US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification