Instrumentation Laboratory recalls HemosIL ReadiPlasTin (Part No. 0020301400) due to variable QC results. All in-date lots affected; customers will switch to HemosIL RecombiPlasTin 2G.
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.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (Part No. 0020301400) because its quality control results are inconsistent. This could lead to inaccurate blood clotting tests, which may affect medical decisions. Affected users should switch to the alternative reagent HemosIL RecombiPlasTin 2G.
The reagent produces inconsistent quality control results, meaning test results may be inaccurate. This could lead to incorrect medical decisions if used for blood clotting tests. However, the hazard does not cause immediate injury or death.
Users of HemosIL ReadiPlasTin for blood clotting tests are affected. Patients and healthcare providers who rely on this reagent for prothrombin time testing are most at risk.
Check for the part number 0020301400 on the reagent label. All in-date lots are affected, so look for the unique device identifier (UDI) 08426950632887.
Replace HemosIL ReadiPlasTin with HemosIL RecombiPlasTin 2G as the alternative prothrombin time reagent.
The recall is due to variable and out of specification quality control results with HemosIL ReadiPlasTin, which could lead to inaccurate blood clotting tests.
Replace it with HemosIL RecombiPlasTin 2G as the alternative prothrombin time reagent.
Yes, all in-date lots of HemosIL ReadiPlasTin (Part No. 0020301400) are affected.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1052-2022 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1052-2022 from Instrumentation Laboratory. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
