China NMPA Product Recall - Tripropylamine buffer, fully automated chemiluminescence immunoassay analyzer

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall for its Tripropylamine Buffer and Fully Automated Chemiluminescence Immunoassay Analyzer, as reported to the National Medical Products Administration (NMPA) on April 24, 2019. The company's headquarters identified product quality issues during complaint assessments. Specifically, the ProCell II M tripropylamine buffer was found to degrade due to bacterial contamination within the analyzer's flow channel. This contamination, combined with other specific operating conditions such as failure to perform daily finalization, the occurrence of certain alarms (e.g., "ProCell On Board Stability Time," "Abnormal Signal Low"), or extended system operation in CLAS connection or rack receiving modes, could lead to signal degradation in the cobase 801 module. The recall addresses these potential performance compromises, ensuring product reliability and patient safety. Roche Diagnostics provided detailed information on affected models and batches in a Medical Device Recall Event Report Form. The NMPA website hosts this information, emphasizing compliance with medical device regulations.