China NMPA Product Recall - Fully automated biochemical and immunoassay analyzer; fully automated chemiluminescence immunoassay analyzer; fully automated glycated hemoglobin analyzer

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall, publicly reported on January 27, 2021, for several of its fully automated diagnostic analyzers. This action follows customer feedback received by Roche Diagnostics headquarters concerning software malfunctions. Specifically, the cobas 8000 series analyzer experienced issues where the system stopped detecting barcode samples and lost some utility program settings. Similar incidents were also noted with the cobas pro integrated solution.

Internal investigations revealed that under certain conditions, clot and bubble detection settings might malfunction without system alerts. This defect could potentially lead to unidentified differential test results, particularly in cases of low sample quality, due to the absence of relevant data markers. Although no adverse patient outcomes have been reported, and the global incidence is very low, the potential for inaccurate test results necessitated this measure.

The recall, conducted under the oversight of the National Medical Products Administration (NMPA), affects fully automated biochemical immunoassay analyzers, chemiluminescence immunoassay analyzers, and glycated hemoglobin analyzers. Roche Diagnostics Products (Shanghai) Co., Ltd. has provided a detailed "Medical Device Recall Event Report Form" containing information on the specific models, specifications, and affected product batches, outlining the required actions for addressing the recalled devices.