China NMPA Product Recall - Urea Assay Kit (Urease-Glutamate Dehydrogenase Method)

On January 11, 2019, Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary recall impacting several of its diagnostic products. The primary reason for this action was the absence of a production date within the product instructions, a crucial piece of information for traceability and quality assurance. The affected products include various assay kits, specifically the Urea Assay Kit (Glutamate Dehydrogenase Method), Glucose Assay Kit (Hexokinase Method), Gamma-Glutamyl Transferase Assay Kit (Rate Method), Cystatin C Assay Kit (Immunoturbidimetric Method), and the Cystatin C Calibrator. These products are registered under specific NMPA certificates, indicating their regulation by the National Medical Products Administration. While no specific inspection dates are provided, the company’s proactive voluntary recall underscores its commitment to rectifying this regulatory non-compliance. The lack of a production date can impede proper inventory management and potentially impact the assessment of product shelf-life, which could compromise product quality and, by extension, patient safety. Detailed information regarding the models, specifications, and batches of the affected products is available in the "Medical Device Recall Event Report Form," guiding stakeholders through the necessary actions to address this issue.