# China NMPA Product Recall - Anti-thyroid peroxidase antibody detection kit (electrochemiluminescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/336b3263-cc64-4b8f-b30e-ba909fafe202/
Source feed: China

> China NMPA product recall for Anti-thyroid peroxidase antibody detection kit (electrochemiluminescence method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published September 04, 2020. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Antith

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its anti-thyroid peroxidase antibody detection kit (electrochemiluminescence assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-09-04
- Product Name: Anti-thyroid peroxidase antibody detection kit (electrochemiluminescence method)
- Recall Level: Level 2 Recall
- Recall Reason: On the cobas e411, cobas e601, and cobas e602 platforms, the interfering concentration of rheumatoid factor (RF) does not reach the concentration stated in the current instruction manual. The relevant information in the instruction manual will be updated.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Antithyroid Peroxidase Antibody Detection Kit (Electrochemiluminescence Assay), as announced by the National Medical Products Administration (NMPA) on September 4, 2020. The recall stems from internal validation experiments revealing that the interference concentration of rheumatoid factor (RF) in the kit did not meet the specifications detailed in the current instructions for use. This issue specifically impacts products used on the cobas e411, cobas e601, and cobas e602 platforms. The company's required action involves updating the instructions for use to reflect accurate RF interference concentrations, with this change applying to all current and future product batches. The Antithyroid Peroxidase Antibody Detection Kit used on the cobas e801 platform remains unaffected. This action underscores the company's commitment to product safety and regulatory compliance under the NMPA's oversight.

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