HemosIL ReadiPlasTin: QC Results Out of Specification - Recall
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60830-hemosil-readiplastin-qc-results-out-of-specification-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/60830-hemosil-readiplastin-qc-results-out-of-specification-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1052-2022
Cite this page
“HemosIL ReadiPlasTin: QC Results Out of Specification - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60830-hemosil-readiplastin-qc-results-out-of-specification-recall. Based on FDA recall #Z-1052-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1052-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Instrumentation Laboratory- Category
Medical device
What to do — step by step
Switch to Alternative Reagent
Replace HemosIL ReadiPlasTin with HemosIL RecombiPlasTin 2G as the alternative prothrombin time reagent.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, South Carolina, Texas, Virginia, West Virginia.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1052-2022 (April 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1052-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.