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

Bio-Rad Life Sciences (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its Glycated Hemoglobin A1c Detection Kit (HPLC Method). This action, announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on December 5, 2018, addresses a critical packaging error. The primary issue involves approximately 91 boxes of the affected detection kits, which were found to contain incorrect calibrators. Specifically, calibrators intended for the Hemoglobin A2/Hemoglobin F Combined Detection Kit (HPLC Method) were mistakenly packaged into the Glycated Hemoglobin A1c kits. This mispackaging could lead to inaccurate test results, potentially impacting patient diagnosis and treatment. The recall covers specific product batches and specifications, detailed in an attached Medical Device Recall Event Report Form. Bio-Rad Life Sciences (Shanghai) Co., Ltd. is undertaking this recall to ensure compliance with medical device regulations and uphold product quality and patient safety standards, demonstrating a commitment to rectifying product discrepancies proactively.