# China NMPA Product Recall - Toxoplasma gondii IgG antibody affinity quality control; Toxoplasma gondii IgG antibody affinity detection kit (electrochemiluminescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/095ed2b2-c058-4b72-aed4-8b946e824d51/
Source feed: China

> China NMPA product recall for Toxoplasma gondii IgG antibody affinity quality control; Toxoplasma gondii IgG antibody affinity detection kit (electrochemiluminescence method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published March 25, 2020. Recall level: Level 3 Recall. On March 25, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III r

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Toxoplasma gondii IgG antibody affinity quality control products and Toxoplasma gondii IgG antibody affinity test kits (electrochemiluminescence assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-03-25
- Product Name: Toxoplasma gondii IgG antibody affinity quality control; Toxoplasma gondii IgG antibody affinity detection kit (electrochemiluminescence method)
- Recall Level: Level 3 Recall
- Recall Reason: During the factory testing of Toxoplasma gondii IgG antibody affinity control products with batch numbers 386030 and 396615, the recovery rate of level 1 was found to be outside the range (>70 Avi%).
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On March 25, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of specific batches of its Toxoplasma gondii IgG antibody affinity quality control products and Toxoplasma gondii IgG antibody affinity detection kits. This action followed an internal discovery by Roche Diagnostics headquarters during factory testing. The issue identified was that the recovery rate of Level 1 of the quality control products (batch numbers 386030 and 396615) exceeded the acceptable threshold of 70 Avi%. This deviation was linked to certain batches of the corresponding assay kits (446940 and 446922). It was noted that the recovery rate of Level 2 and patient samples remained unaffected. The recall was reported via the Shanghai Municipal Drug Administration website under the oversight of the National Medical Products Administration (NMPA), which hosts the website and provides regulatory oversight. Roche Diagnostics Products (Shanghai) Co., Ltd. is taking responsibility by recalling the affected medical devices to ensure product quality and patient safety, as detailed in the Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/