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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

Instrumentation Laboratory Coagulation Reagent Recalled for Microbe Risk

Agency Publication Date: January 15, 2026
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Summary

Instrumentation Laboratory is recalling 7,720 units of its coagulation reagent due to potential microbial contamination. This product is used in laboratories to monitor heparin therapy and evaluate intrinsic coagulation pathways. Affected units can be identified by part number 0020006800 and lot number N1136730, which has an expiration date of December 31, 2025. Laboratory supervisors should stop using this product immediately to avoid inaccurate diagnostic results.

Risk

The potential for microbial contamination can compromise the accuracy of blood coagulation tests. Inaccurate results could lead to improper management of patients undergoing heparin therapy or those with blood-clotting disorders.

What You Should Do

  1. This recall affects the Instrumentation Laboratory coagulation reagent used for evaluating the intrinsic coagulation pathway and monitoring heparin therapy.
  2. Identify affected products by looking for part number 0020006800, UDI-DI 08426950078920, and lot number N1136730 with an expiration date of 12/31/2025.
  3. Stop using the recalled product immediately.
  4. Contact Instrumentation Laboratory or your medical equipment distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

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: Instrumentation Laboratory Coagulation Reagent
Variants: APTT substitution test reagent, Heparin therapy monitoring reagent
Model / REF:
0020006800
Lot Numbers:
N1136730 (Exp 12/31/2025)
UDI:
08426950078920

Used for evaluation of the intrinsic coagulation pathway.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98166
Status: Active
Manufacturer: Instrumentation Laboratory
Sold By: Medical distributors; Hospitals; Clinical laboratories
Manufactured In: United States
Units Affected: 7,720 units
Distributed To: California, Florida, Illinois, Minnesota, Mississippi, Nebraska, Ohio, Texas, Wisconsin

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.