Instrumentation Laboratory is recalling approximately 521 ACL Elite and Elite Pro analyzers in the United States (and over 3,000 units globally) to remove the test definition for HemosIL Liquid Anti-Xa (Part Numbers 0020302600 and 0020302601) from the instrument software. These instruments are used in clinical laboratories for blood coagulation and fibrinolysis testing. The removal of this specific test definition is necessary to ensure the accuracy and reliability of diagnostic results for patients requiring Anti-Xa monitoring.
The presence of the specific test definition for HemosIL Liquid Anti-Xa on these instruments may lead to incorrect test configurations or results. Incorrect results in hemostasis testing could potentially lead to improper clinical management of patients on anticoagulant therapy.
Removal of test definition from instrument software.
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.
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Sources: FDA iRES · Raw API Response
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