China NMPA Product Recall - Cytomegalovirus IgG antibody affinity quality control; Cytomegalovirus IgG antibody affinity test kit (electrochemiluminescence method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Cytomegalovirus IgG Antibody Affinity Quality Control and the accompanying Cytomegalovirus IgG Antibody Affinity Assay Kit (Electrochemiluminescence Method). This recall, announced by the National Medical Products Administration (NMPA) on November 11, 2020, addressed a performance anomaly. The issue arose when specific batches of the quality control product (batch 435100) were used in conjunction with designated assay kit batches (450080 and 450336), leading to Level 1 quality control results that surpassed acceptable limits. An internal inquiry by Roche Diagnostics pinpointed a specific raw material in the affected quality control product as the underlying cause. Despite this deviation, the investigation concluded that patient diagnostic results were unaffected, and associated medical risks were successfully ruled out. Furthermore, the product maintained its usability after adjustments were made to its target values and ranges. This recall underscores the company's adherence to the medical device regulatory framework governed by China's NMPA and the Shanghai Municipal Drug Administration. The primary required action was the implementation of this Class III recall for the identified product batches.