Instrumentation Laboratory is recalling approximately 2,068 ACL TOP Family 50 Series diagnostic systems in the U.S. and over 6,000 units globally due to a defect where samples could be misidentified under specific conditions. These devices are used in laboratories to perform blood coagulation and fibrinolysis testing, which is critical for assessing thrombosis and bleeding risks. If a sample is incorrectly assigned to the wrong patient, it could lead to incorrect medical results and improper patient management. Consumers should contact the manufacturer or their healthcare provider for further instructions regarding this voluntary firm-initiated recall.
The device may incorrectly assign a test result to the wrong patient sample. This misidentification could cause healthcare providers to make critical treatment decisions based on inaccurate data, potentially leading to patient harm from improper anticoagulation therapy or missed diagnoses.
Correction/Software Update
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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