China NMPA Product Recall - Glycated Hemoglobin A1c Detection Kit (HPLC Method)

On April 17, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Glycated Hemoglobin A1c Detection Kit (HPLC Method), registered under Certificate No. 20172402233. This action was reported to the Shanghai Food and Drug Administration, operating under the National Medical Products Administration (NMPA) framework in China.The recall was prompted by significant discrepancies in the product's cleaning buffer components compared to its officially registered specifications. Specifically, two distinct kit configurations were identified with incorrect contents. One kit was found to contain three bottles of cleaning buffer 2 but completely lacked cleaning buffer 1, diverging from the approved composition of two bottles of cleaning buffer 1 and one bottle of cleaning buffer 2. A second affected kit contained one bottle of washing buffer 1 and two bottles of washing buffer 2, again not conforming to the registered component quantities.These packaging inconsistencies indicate that the kits were not assembled according to their officially documented and approved configurations. As a direct consequence of these manufacturing and packaging deviations, Bio-Rad Life Sciences (Shanghai) Co., Ltd. is taking the required action to remove the non-conforming products from the market. Further specific details regarding the affected product models, specifications, and batch numbers are provided in the accompanying Medical Device Recall Event Report Form.