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. initiated a voluntary Class III recall of its Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. This recall, reported via the Shanghai Municipal Drug Administration Website on May 11, 2021, addresses a critical product performance issue. The main problem identified is that when a photometer lamp in these fully automated biochemical analyzers exceeds its service life, it can unpredictably enhance the intensity of one or more of 11 wavelengths. This enhancement may cause the photometer to saturate, potentially leading to erroneous and unmarked optical test results. While an operator event code and alarm are generated if lamp intensity falls outside acceptable ranges, the risk of inaccurate results before such an alarm is a significant concern. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), Siemens Healthcare Diagnostics Inc. is taking proactive steps to mitigate this risk. The required action involves a voluntary recall of affected devices, specified by their registration certificate numbers and detailed in an accompanying Medical Device Recall Event Report Form, aiming to ensure the accuracy and reliability of diagnostic testing.