China NMPA Product Recall - Attellica CH Analyzer (fully automated biochemical analyzer); Attellica Solution Chemistry System (fully automated biochemical analyzer); Attellica Solution Chemistry-Immunoassay System (fully automated biochemical and immunoassay analyzer)

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. announced a voluntary Level III recall on November 24, 2021, for several of its Attellica automated biochemical and immunoassay analyzer systems. Affected products include the Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. The recall stems from a software issue in versions v1.25.1 and earlier of the Attellica CH / 930 fully automated biochemical analyzer. Specifically, during open-channel testing, the Test Definition (TDef) parameter has been observed to revert to its default value, and Onboard Stability (OBS) fails to update after manual changes. This malfunction could potentially impact the accuracy and reliability of diagnostic results. The recall is overseen by the National Medical Products Administration (NMPA), China's regulatory authority for medical devices. As a Level III recall, it addresses an issue with a low probability of causing serious health consequences but necessitates corrective action to prevent potential testing inaccuracies. Siemens is providing detailed information on affected product models, specifications, and batch numbers through a "Medical Device Recall Event Report Form" to ensure compliance with regulatory standards and maintain product integrity.