China NMPA Product Recall - S100 Calibration Solution (S100 CalSet)

Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its S100 calibration solution (S100 CalSet), registered under Certificate No.: 20162404160. This recall, published on December 28, 2021, by the National Medical Products Administration (NMPA) and reported by the Shanghai Municipal Drug Administration, followed an internal company investigation.

The core issue identified was a critical discrepancy in the descriptions of the reagent-working solution between the English and Chinese instructions provided with the S100 calibration solution. This inconsistency could potentially lead to incorrect product preparation or use.

While formal inspection dates are not specified, the recall demonstrates Roche Diagnostics' response to an internally discovered quality control issue. The company is operating within the regulatory framework of the NMPA, which governs medical device recalls in China. The required action involves the comprehensive execution of this Class III recall, which encompasses specific product models, specifications, and batches, as detailed in the "Medical Device Recall Event Report Form." This measure aims to prevent any adverse impacts resulting from the misleading instructions and uphold product integrity and patient safety.