# China NMPA Product Recall - PSA antibody reagent (immunohistochemistry)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ventana-medical-systems/3149658c-467d-4d61-8aaf-9f81273f8912/
Source feed: China

> China NMPA product recall for PSA antibody reagent (immunohistochemistry) by Ventana Medical Systems published March 31, 2021. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd., on behalf of Ventana Medical Systems, initiated a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its PSA antibody reagent (immunohistochemistry).
- Company Name: Ventana Medical Systems
- Publication Date: 2021-03-31
- Product Name: PSA antibody reagent (immunohistochemistry)
- Recall Level: Level 3 Recall
- Recall Reason: The label on the PSA antibody reagent (immunohistochemistry) vial with batch number F27352 is incorrect. The vial label and contents correspond to anti-CD30 (Ber-H2) antibody, while the vial barcode label and outer box label correspond to PSA antibody reagent (immunohistochemistry).
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Ventana Medical Systems
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/ventana-medical-systems/ae4f7b4b-f93d-4f88-a773-d26f31c584e0/