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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

HemosIL Heparin Calibrators Recalled for Inaccurate Test Results

Agency Publication Date: January 24, 2025
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Summary

Instrumentation Laboratory is recalling approximately 22,514 units of HemosIL Heparin Calibrators (Part Number 0020300600). The recall was initiated because the product may show lower than expected quality control results, which could lead to inaccurate diagnostic test readings in laboratory settings. There have been no reports of incidents or injuries related to this issue to date.

Risk

Inaccurate test results from these calibrators could cause healthcare providers to miscalculate heparin levels in patients, potentially leading to improper medication dosing and serious health complications.

What You Should Do

  1. This recall affects HemosIL Heparin Calibrators with Part Number 0020300600 and UDI-DI 08426950472483.
  2. The affected products include several specific lot numbers such as N0128933, N0220450, N0522479, and N0724070. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: HemosIL Heparin Calibrators (Part Number 0020300600)
Variants: in vitro diagnostic
Model / REF:
0020300600
Lot Numbers:
N0128933
N0220450
N0522479
N0724070
N1026509
N0239584
N0531891
N0733658
N0249207
N0442161
N0744673
N1147734
N020463
N0250464
N0452277
N0553155
N0754506
UDI:
08426950472483

10,952 units (5,303 US, 5,649 OUS) plus an additional 11,562 units updated 4/15/2026.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96044
Status: Active
Manufacturer: Instrumentation Laboratory
Sold By: Medical supply distributors; Direct hospital sales
Manufactured In: United States
Units Affected: 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)
Distributed To: Nationwide
Agency Last Updated: April 15, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.