China NMPA Product Recall - High Sensitivity C Reactive Protein Calibrator (hsCRP CAL)

The National Medical Products Administration (NMPA) issued an announcement regarding a voluntary Class III recall initiated by Siemens Healthcare Diagnostics Inc. This recall pertains to specific batches of their High Sensitivity C Reactive Protein Calibrator (hsCRP CAL), which is registered under certificate number 20192400513. The issue, reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., centers on a critical performance deviation where certain product batches exhibited inaccurate results. Crucially, these deviations were undetectable through standard quality control procedures, posing a potential risk to patient diagnostics. Under the NMPA's regulatory oversight, Siemens Healthcare Diagnostics Inc. is undertaking this voluntary recall to address the product's non-conformance. The Class III designation indicates that the product issue is unlikely to cause adverse health consequences but still warrants corrective action. Further detailed information, including specific product models and batch numbers, is available in the accompanying 'Medical Device Recall Event Report Form'.