# China NMPA Product Recall - Free thyroxine assay kit (electrochemiluminescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/b0910788-609a-4729-aafd-752ce1e92502/
Source feed: China

> China NMPA product recall for Free thyroxine assay kit (electrochemiluminescence method) by Roche Diagnostics GmbH published November 07, 2018. Recall level: Level 3 Recall. Roche Diagnostics GmbH initiated a Class III voluntary recall of its Free Thyroxine Assay Kit (Elect

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH is voluntarily recalling its free thyroxine assay kit (electrochemiluminescence assay).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2018-11-07
- Product Name: Free thyroxine assay kit (electrochemiluminescence method)
- Recall Level: Level 3 Recall
- Recall Reason: The biotin interference threshold for the specific batch of the above-mentioned free thyroxine assay kit (electrochemiluminescence assay) has been reduced. FT4 recovery may vary by more than 20% only when patient samples contain high concentrations of biotin (≥266 nmol/L or 65 ng/mL).
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics GmbH initiated a Class III voluntary recall of its Free Thyroxine Assay Kit (Electrochemiluminescence Imaging), identified by National Medical Device Registration Certificate 20162404445. The National Medical Products Administration (NMPA) publicly reported this on November 7, 2018, following Roche Diagnostics Products (Shanghai) Co., Ltd.'s report on October 19, 2018. The main issue was a lowered biotin interference threshold in specific batches (e.g., 304692, 331797, 304694, 331807) of the kit. This defect could cause the Free Thyroxine (FT4) recovery rate to vary by over 20% in patient samples containing high concentrations of biotin (≥266 nmol/L or 65 ng/mL). The recall level signifies that the use of, or exposure to, the product is not likely to cause adverse health consequences. While the recall is global, Roche Diagnostics Products (Shanghai) Co., Ltd. confirmed that the affected product batches were not imported or sold within China. Consequently, no direct actions were required for the Chinese market concerning these specific batches, as they were deemed unaffected.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-gmbh/2a33a337-c39d-4329-b659-c812f690f94b/