Recall of HemosIL AcuStar HIT-IgG(PF4-H) Test Kits Due to False Negative Risk
Instrumentation Laboratories (Werfen) has issued an urgent removal for specific lots of the HemosIL AcuStar HIT-IgG(PF4-H) device due to a performance issue. The affected lots have been found to exhibit a negative bias, which can cause patient sample results to fall incorrectly below the assay cut-off and yield false negative readings.
A false negative result for heparin-induced thrombocytopenia (HIT) can delay proper recognition of the condition and clinical management, potentially leading to continued heparin exposure and increased risk of thrombotic complications in affected patients. The manufacturer advises checking inventory, destroying the affected lots following facility procedures, and documenting the destruction.
Clinicians and laboratory personnel should transition to alternative methods for HIT antibody testing due to expected supply interruptions. Facilities must consult their local representatives for guidance and rely on local procedures and clinical judgment regarding the review of previously reported patient results or repeat testing.
Key points
- Affected products include specific lots of HemosIL AcuStar HIT-IgG(PF4-H) part numbers 0009800127 and 0009802028.
- A performance issue causes an unreliably detected negative bias that can result in false negative antibody readings.
- False negative results may delay diagnosis of heparin-induced thrombocytopenia and prolong harmful heparin exposure.
- Users are instructed to check inventory, destroy affected stock, document destruction, and find alternative testing methods.
What it means for you
Healthcare providers and laboratory staff utilizing HIT-IgG assays should verify their current inventory against the recalled lot numbers and remove any affected testing kits from service immediately. Because supply interruptions are anticipated, laboratories must identify alternative testing methods and consult appropriate clinical leadership or local regulatory guidance regarding previous patient results. Clinicians in Pakistan should check with local suppliers and DRAP for any information regarding the availability or status of these specific testing devices locally.
Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.