China NMPA Product Recall - α1-Microglobulin Detection Kit (Immunoturbidimetric Method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its "α1-Microglobulin Detection Kit (Immunoturbidimetric Assay)" on November 10, 2021. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), stemmed from an internal company investigation. The investigation determined that the diagnostic kit's imprecision had increased, causing it to fail its established product specifications. The affected product is identified by Registration Certificate No.: 20172401204. The recall is classified as Class III, indicating that while the product's use is unlikely to cause serious adverse health consequences, the quality deviation requires its removal from the market to uphold product integrity and regulatory standards. Detailed information regarding specific product models, specifications, and batches involved is provided in the "Medical Device Recall Event Report Form."