Lower riskMedical device recall · FDA · Published October 13, 2021
HemosIL ReadiPlasTin (20mL) recall: Risk of inaccurate test results
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.
Take action
Contact the company
📍Recalling firmInstrumentation Laboratory180 Hartwell Rd · Bedford, MA 01730-2443
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/61689-hemosil-readiplastin-20ml-recall-risk-of-inaccurate-test-results.
“HemosIL ReadiPlasTin (20mL) recall: Risk of inaccurate test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61689-hemosil-readiplastin-20ml-recall-risk-of-inaccurate-test-results. Based on FDA recall #Z-0276-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0276-2022%22&limit=1).
The FDA announced on 2021-10-13 that Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (20 mL) due to performance issues that may cause erroneous test results. The agency issued recall number Z-0276-2022 for the in vitro diagnostic thromboplastin reagent.
How to tell if you have it
Brand: Instrumentation Laboratory
Product: HemosIL ReadiPlasTin (20 mL)
Part number: 0020301400
Lot codes: N0705526, N0806224
UDI: 08426950632887
The hazard
The firm has received customer reports of performance issues with the affected lots, 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.
Context
GovInfoNow's records show Instrumentation Laboratory has 13 other recalls on record since 2021-08-25. Recent brand recalls include the GEM Premier 5000 PAK lysing bag solution risk (2026-05-21), the GEM Premier 5000 blood analyzer wrong patient ID assignment risk (2026-05-08), and GEM PAKs causing repeated warm-up errors (2026-01-20). Other recent recalls of similar products include the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07), the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), and the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18).
How to tell if you have this one
Check for lot numbers N0705526 or N0806224 on the product label. The product is an in vitro diagnostic thromboplastin reagent sold by Instrumentation Laboratory.
Brand
Instrumentation Laboratory
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for lot numbers N0705526 or N0806224 on the HemosIL ReadiPlasTin (20 mL) reagent label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Illinois, Iowa, Kansas, Maine, Michigan, New York, North Carolina, Oklahoma, South Carolina, Virginia.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0276-2022 (October 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0276-2022 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.