China NMPA Product Recall - Unbound estriol assay kit (chemiluminescence method)

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Unbound Estriol Assay Kit (Chemiluminescence Method) on September 8, 2020. This action, reported through the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, was prompted by an internal investigation revealing potential issues with specific reagent batches. The company identified that approximately 3% of patient samples could exhibit slightly elevated interference related to bovine alkaline phosphatase when using the affected kits. This interference posed a risk to the accuracy of test results. While no specific inspection dates were provided, the company’s proactive reporting highlights its compliance with regulatory expectations regarding product safety and quality. The required action involves the recall of the specified medical device batches, with detailed information available in the "Medical Device Recall Event Report Form" referenced by the NMPA. This ensures the removal of potentially unreliable products from circulation to safeguard patient diagnostic accuracy.