# China NMPA Product Recall - Dystrophin 1 (DYS1) antibody reagent, dystrophin 2

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-biosystems-newcastle-ltd/d16619bb-969b-4407-ade3-4c0e25f47c77/
Source feed: China

> China NMPA product recall for Dystrophin 1 (DYS1) antibody reagent, dystrophin 2 by Leica Biosystems Newcastle Ltd published May 19, 2025. Recall level: Level 3 Recall. On May 19, 2025, Leica Biosystems Newcastle Ltd initiated a Class III voluntary recall of specific m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Leica Biosystems Newcastle Ltd is voluntarily recalling products including dystrophin 1 (DYS1) antibody reagents.
- Company Name: Leica Biosystems Newcastle Ltd
- Publication Date: 2025-05-19
- Product Name: Dystrophin 1 (DYS1) antibody reagent, dystrophin 2
- Recall Level: Level 3 Recall
- Recall Reason: Incorrect product label
- Discovering Company: Leica Biosciences (Shanghai) Co., Ltd.
- Manufacturing Company: Leica Biosystems Newcastle Ltd
- Summary: On May 19, 2025, Leica Biosystems Newcastle Ltd initiated a Class III voluntary recall of specific medical device products, as reported by Leica Biotechnology (Shanghai) Co., Ltd. The affected items include the Dystrophin 1 (DYS1) Antibody Reagent Novocastra Lyophilized Mouse Monoclonal Antibody Dystrophin (Rod Domain), registered under National Medical Device Registration No. 20240314, and the Dystrophin 2 Lyophilized Mouse Monoclonal Antibody Dystrophin (C-terminus), registered under National Medical Device Registration No. 20240315. The primary reason for this recall is incorrect product labeling by the manufacturer. While the document does not specify inspection dates, the recall was publicly announced on the mentioned date by the National Medical Products Administration (NMPA). This regulatory body is responsible for overseeing such actions to ensure medical product safety and compliance. It is crucial to note that the products implicated in this recall were not imported into the Chinese market. Companies are required to address such discrepancies promptly through actions like voluntary recalls to maintain product integrity and ensure accurate information is conveyed to users, preventing potential misidentification or misuse of critical diagnostic reagents. Detailed batch-specific information is contained within the 'Medical Device Recall Event Report Form'.

Company: https://www.globalkeysolutions.net/companies/leica-biosystems-newcastle-ltd/3b10b0b4-f38e-4093-b3e8-97aaf3e03c6b/