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Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG (PF4-H)
The FDA is aware that Instrumentation Laboratories (Werfen) has issued letters to affected customers recommending certain lots of HemosIL AcuStar HIT-IgG(PF4-H) be removed from where they are used or sold.
Instrumentation Laboratories (Werfen) stated that a performance issue has been identified affecting Lot No. B40005, B40006, B38062, and B38063 of HemosIL AcuStar HIT-IgG(PF4-H), Part No. 0009800127 and 0009802028. Customer complaints have reported obtaining an invalid calibration curve and in one complaint, a negative mean bias of 47% with patient samples. Werfen’s investigation has confirmed performance variability (negative bias of 20-35%) with the affected lots that may not be reliably detected through routine calibration and quality control testing. The root cause investigation is ongoing.
This performance issue may result in a negative bias that could cause sample results to be incorrectly reported below the assay cut-off (1.00 U/mL) and, therefore, be interpreted as “HIT IgG Antibody negative.” A false positive negative result may delay recognition of HIT and influence clinical management. In patients with HIT, continued exposure to heparin may increase the risk of thrombotic complications.
As of September 3, Instrumentation Laboratories (Werfen) has reported no serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Werfen Client Services at 1-800-955-9525.
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