China NMPA Product Recall - HER-2/neu protein assay kit (chemiluminescence method); HER-2/neu protein calibrators

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall on September 2, 2020, for specific batches of its HER-2/neu protein assay kit (chemiluminescence immunoassay) and HER-2/neu protein calibrator products. This action was reported through the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, the relevant regulatory bodies. The recall stems from the company's discovery that certain product batches demonstrated a positive bias compared to Siemens' internal quality standards. This bias was proportional to the detection range and exceeded the upper limits outlined in the product instructions, which could lead to inaccurate positive bias in analytical testing results. As a required action under the NMPA's framework, Siemens is recalling the affected products, identified by Registration Certificate Nos.: 20153400554 and 20153400557. Details on specific models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form," ensuring that integrity and reliability in diagnostic testing are maintained.