China NMPA Product Recall - HemosIL von Willebrand Factor Antigen Detection Kit (Immunoturbidimetric Assay)

Instrumentation Laboratory Co., Ltd., through its reporter Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a voluntary Class III recall for specific batches of its HemosIL von Willebrand Factor Antigen (Immunoturbidimetric Assay), Catalog No.: 0020002300. This action, reported to the National Medical Products Administration (NMPA), followed internal testing by Instrumentation Laboratory Co., Ltd. The testing revealed that four product batches did not meet their labeling requirements. The core issue concerned the potential for falsely elevated test results for von Willebrand Factor Antigen (VWF:Ag) when patient samples contain high levels of rheumatoid factor (exceeding 750 IU/mL), particularly when measured on the 50 series instruments. Although no customer complaints were reported, this labeling discrepancy could mask abnormally low VWF:Ag levels, potentially leading to misclassification of von Willebrand Disease. However, the company assessed the safety risk as negligible, as a VWD diagnosis relies on broader clinical evaluation and repeat validation tests, not solely on a single VWF:Ag result. The required actions include revising the product's statement regarding rheumatoid factor interference and executing the voluntary Class III recall to address the non-compliance.