Lower riskMedical device recall · FDA · Published February 3, 2025
HemosIL LMW Heparin Controls Recall: Quality Control Issues May Delay Patient Testing
Instrumentation Laboratory recalls HemosIL LMW Heparin Controls (Part 0020300200) due to inconsistent quality control results that may cause patient testing delays. Affected units include specific lot numbers.
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Take action
Contact the company
📍Recalling firmInstrumentation Laboratory180 Hartwell Rd · Bedford, MA 01730-2443
“HemosIL LMW Heparin Controls Recall: Quality Control Issues May Delay Patient Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52982-hemosil-lmw-heparin-controls-recall-quality-control-issues-may-delay. Based on FDA recall #Z-2323-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2025%22&limit=1).
The Food and Drug Administration announced on Feb. 3, 2025, that Instrumentation Laboratory is recalling HemosIL LMW Heparin Controls due to quality control failures. The agency issued recall number Z-2323-2025 for the device.
Multiple complaints indicate lower than expected quality control results and QC recovery below the package insert acceptance range when testing with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some instances, failure to pass quality control resulted in patient testing delays.
Context
GovInfoNow's records show Instrumentation Laboratory has 13 other recalls on record since Aug. 25, 2021. Other recent recalls of similar products include Accriva Diagnostics directCHECK ACT-LR blood control with incorrect labeling (April 30, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall regarding risk of inaccurate test results (July 13, 2026), and Medtronic HR-ACT Cartridges Recall where dry blood on labels may cause contamination (Oct. 20, 2025).
How to tell if you have this one
Check for part number 0020300200 on the product label. The affected units include specific lot numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397.
Brand
Instrumentation Laboratory
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for part number 0020300200 on the HemosIL LMW Heparin Controls label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, Germany, Gibraltar, Greece,…” 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 7 months 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-2323-2025 (February 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2323-2025 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.