China NMPA Product Recall - PSA antibody reagent (immunohistochemistry)

Roche Diagnostics Products (Shanghai) Co., Ltd., on behalf of Ventana Medical Systems, initiated a voluntary Class III recall of its PSA antibody reagent (immunohistochemistry), identified by Registration Certificate No.: 20180622. This action, reported to the National Medical Products Administration (NMPA) on March 31, 2021, stemmed from an internal complaint investigation.The core issue involved mislabeling on vials from batch number F27352. Specifically, the internal vial label and its contents corresponded to an anti-CD30 (Ber-H2) antibody. However, the vial’s barcode and the outer box label incorrectly identified the product as PSA antibody reagent (immunohistochemistry).Roche Diagnostics assessed the potential health risk as extremely low due to the ease with which this labeling discrepancy can be identified by users. The company is taking proactive measures to address this product inconsistency. Additional detailed information regarding specific affected product models, specifications, and batches is available in the associated Medical Device Recall Event Report Form.