Instrumentation Laboratory — Class I: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory has initiated a Class I recall for the HemoslL AcuStar HIT-lgG(PF-4) in vitro diagnostic due to potential invalid calibration curves or negative mean bias reaching 47% in patient samples.
This recall affects clinical laboratories utilizing the HemoslL AcuStar HIT-lgG(PF-4) (Part Number 0009802028) and the manufacturer, Instrumentation Laboratory.
A Class I classification indicates the highest level of risk, where the FDA determines there is a reasonable probability that use of the product will cause serious adverse health consequences or death. A negative mean bias of 47% suggests a significant risk of false-negative results, which in the context of HIT-lgG testing, could lead to delayed diagnosis or inappropriate clinical management of heparin-induced thrombocytopenia.
Laboratories should immediately identify and sequester affected part numbers (0009802028). QA teams should initiate a retrospective review of test results generated with these kits to assess clinical impact, while Regulatory teams should ensure all OUS reporting requirements are met for this ongoing Class I action.
Class I. Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.. Product: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only). Firm: Instrumentation Laboratory (Bedford MA United States). Status: Ongoing.
Open in openFDA / FDA.gov