China NMPA Product Recall - Vitamin B12 Assay Kit (Chemiluminescent Microparticle Immunoassay)

On December 26, 2018, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Vitamin B12 Assay Kit (Chemiluminescent Microparticle Immunoassay). This action was taken due to manufacturing discrepancies where some product batches contained incorrect components. Specifically, affected kits were identified as potentially including two bottles of diluent (catalog number 7K61J) or two bottles of pretreatment solution 1 (catalog number 7K61U), rather than the correct combination of components. The recall was reported through the National Medical Products Administration (NMPA) and falls under the oversight of the Shanghai Food and Drug Administration, which issued the product's Medical Device Registration Certificate (No.: 20162404541). The company's proactive measure aimed to address these component errors, which could impact the accurate performance of the assay kit. Abbott Trading (Shanghai) Co., Ltd. is committed to ensuring product quality and patient safety. Further specific details on the affected product models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form. This voluntary recall demonstrates the company's adherence to regulatory expectations and its commitment to resolving product-related issues promptly.