China NMPA Product Recall - Urine sediment analyzer; Fully automated urine analyzer

The National Medical Products Administration (NMPA) announced on May 26, 2020, that Roche Diagnostics Products (Shanghai) Co., Ltd. is initiating a voluntary Class II recall of its urine sediment analyzers and fully automated urine analyzers. The recall specifically impacts the cobas 6500 fully automated modular urine analysis systems operating with software versions 2.2.0 through 2.2.8, running on Windows Embedded POSReady 2009. The primary issue identified is a sample result mismatch problem. This occurs when the solid waste bin of the counting plate within the cobas 6500 system becomes full, subsequently triggering error code 70401. Under these conditions, a discrepancy in test results was observed between the cobas u 601 fully automated urine analyzer and the cobas u 701 urine sediment analyzer when processing the same sample. While an investigation revealed no adverse impact on patients from this specific event, Roche Diagnostics is proactively recalling the affected devices. This action is taken under the regulatory framework of the NMPA to ensure product reliability and patient safety. The required action for the company is to implement this voluntary recall, with specific models, specifications, and batch details provided in the "Medical Device Recall Event Report Form" for further guidance.