Instrumentation Laboratory is recalling 41,824 units of HemosIL LMW Heparin Controls (Part Number 0020300200). The recall was issued after reports that the product produced quality control results that were lower than expected or outside of the acceptable range when used with certain testing reagents. This defect has caused delays in patient testing in multiple instances, though no physical injuries have been reported.
If quality control results fail to meet the required standards, diagnostic testing for patients can be delayed or yield unreliable data. This specifically affects laboratories using HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator to monitor heparin levels.
Laboratory product corrective action
Recalled for quality control recovery below the lower limit of the package insert acceptance range.
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.
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 · Raw API Response
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