China NMPA Product Recall - Cytomegalovirus IgM Antibody Detection Kit (Electrochemiluminescence Assay)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall of its Cytomegalovirus IgM Antibody Detection Kits (Elecsys CMV IgM Antibody Detection Kit, item 04784618190) on October 20, 2015, following an internal report dated September 1, 2015. The recall was prompted by routine quality control testing at Roche Diagnostics headquarters, which identified a critical issue. When specific batches of the detection kit were used in conjunction with certain universal diluent batches (03183971-122 and 11732277-122), a weakened detection signal occurred. This deficiency could lead to low or abnormal test results, including false negatives, for cytomegalovirus IgM antibodies in human serum and plasma. Operating under the oversight of the National Medical Products Administration (NMPA) in China, Roche Diagnostics demonstrated a commitment to patient safety by proactively addressing this product quality concern. To rectify the issue and prevent future occurrences, Roche headquarters announced that the problematic component in the universal diluent would be discontinued. Furthermore, future alternative components would be optimized to ensure the reliability and accuracy of the diagnostic kits. This recall impacts 3299 boxes produced globally, with 3073 boxes sold in China, affecting item numbers 179689, 182962, 187017, and subsequent batches.