China NMPA Product Recall - Free Triiodothyronine Assay Kit (Chemiluminescence Method)

On September 18, 2015, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Access Free Triiodothyronine (Free T3) Assay Kits (P/N A13422, Lot No. 431433). This action, reported to the National Medical Products Administration (NMPA), stemmed from the discovery of incorrect reagent volume filling in some kits. Specifically, one or more reagent compartments within the affected batch, comprising 9541 units distributed globally and within China, contained an insufficient volume of reagent. This manufacturing deviation could potentially impact the accuracy and reliability of diagnostic test results. Under the regulatory framework of the NMPA (formerly CFDA), which oversees medical device safety, Beckman Coulter implemented several corrective actions. The company immediately halted shipments of the affected products to prevent further distribution and notified customers to cease using them. All affected units are being recalled from the market, and appropriate compensation is being provided to impacted customers, aiming to mitigate potential risks and ensure compliance with quality standards.