Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20mL) lot N0705526 and N0806224 due to potential inaccurate test results. Affected users should check their product labels.
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.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (20 mL) reagent lots N0705526 and N0806224 because customer reports show increased imprecision and potential for inaccurate test results. This could lead to incorrect medical conclusions if quality controls aren't properly followed.
The reagent may produce imprecise results, causing quality controls to fail. If these controls don't pass for each vial, there's a risk of reporting incorrect test outcomes, which could affect medical decisions.
Users of HemosIL ReadiPlasTin (20 mL) reagent for in vitro diagnostic testing. Laboratory staff and healthcare providers who use the product are most at risk of inaccurate results.
Check for lot numbers N0705526 or N0806224 on the product label. The product is an in vitro diagnostic thromboplastin reagent sold by Instrumentation Laboratory.
Look for lot numbers N0705526 or N0806224 on the HemosIL ReadiPlasTin (20 mL) reagent label.
The reagent may cause increased imprecision and failed quality controls, potentially leading to inaccurate test results.
Check for lot numbers N0705526 or N0806224 on the HemosIL ReadiPlasTin (20 mL) reagent label.
The recall record does not specify a remedy; users should check their product label and contact the manufacturer if needed.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-0276-2022 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0276-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
