Instrumentation Laboratory is recalling approximately 4,506 units of HemosIL SynthAFax Partial Thromboplastin Time Tests because they were manufactured with double the intended concentration of preservative. These products are used in laboratory settings for blood coagulation testing. The recall affects specific lot numbers with expiration dates ranging from June 2026 to June 2027.
The excessive amount of preservative in these test kits may interfere with testing accuracy, which could lead to incorrect medical assessments of a patient's blood clotting time.
Recalled lots were manufactured with double the amount of preservative concentration.
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Sources: FDA iRES · Raw API Response
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