HemosIL Heparin Calibrators Recall: QC Results May Be Unreliable
Instrumentation Laboratory recalls HemosIL Heparin Calibrators (Part 0020300600) due to potential lower quality control results. Affected units include specific lot numbers listed in the recall notice.
Lower-risk recall
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
Contact the company
What happened, in plain English
Instrumentation Laboratory is recalling HemosIL Heparin Calibrators with part number 0020300600 because they may produce QC results that are too low. This could lead to inaccurate blood tests if used in medical settings. Read more at govinfonow.com/recall/53278-hemosil-heparin-calibrators-recall-qc-results-may-be-unreliable.
Source Summary by GovInfoNow · govinfonow.com/recall/53278-hemosil-heparin-calibrators-recall-qc-results-may-be-unreliable · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1020-2025
Cite this page
“HemosIL Heparin Calibrators Recall: QC Results May Be Unreliable.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53278-hemosil-heparin-calibrators-recall-qc-results-may-be-unreliable. Based on FDA recall #Z-1020-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1020-2025%22&limit=1).
Why it’s dangerous
The calibrators may indicate lower quality control results than expected, potentially leading to inaccurate blood test results. This could affect the reliability of diagnostic tests if the device is used in medical settings.
Who’s affected
Healthcare professionals using these calibrators for blood tests are most at risk. Patients relying on accurate test results from these devices may be affected.
How to tell if you have this one
Check for part number 0020300600 on the device. Affected units include specific lot numbers listed in the recall notice (N0128933, N0220450, etc.).
- Brand
Instrumentation Laboratory- Category
Medical device
What to do — step by step
Check Device Lot Number
Look for lot numbers on the device, such as N0128933, N0220450, or others listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 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.
Questions people ask
Which lot numbers are affected by this recall?
Affected lot numbers include N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673, and others listed in the recall notice.
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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-1020-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1020-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.