China NMPA Product Recall - Coagulation quality control materials

Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Coagulation Quality Control Materials. Formally reported on September 18, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 7, 2016, the recall addresses a critical product stability issue. The primary concern is that Level 1 of the coagulation quality control material may not maintain its stated stability requirements for storage at 2-25 degrees Celsius after opening, conflicting with the product's instructions for use. This affects the material's intended purpose in monitoring the precision of citrate coagulation systems. Affected products include models 744 and 745X, specifically batch number 78421. Bio-Rad confirmed that this instability issue is limited to Level 1, with other instructions and the stability of Level 2 and Level 3 products remaining unaffected. In response, the company has implemented corrective actions. For products currently in stock, a product quality notice will be attached before shipment. For materials already distributed, Bio-Rad is issuing product quality notices and feedback forms to customers through its distributor network. This measure ensures all users are fully informed about the updated storage instructions for Level 1, thereby preventing potential impacts on diagnostic accuracy.