# China NMPA Product Recall - Estradiol Assay Kit (Electrochemiluminescence Reduction) / (Estradiol II); Estradiol Assay Kit (Electrochemiluminescence Reduction) / (Estradiol III)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/0e0fe8f2-309a-4e18-ad4f-e01a7d9a10c8/
Source feed: China

> China NMPA product recall for Estradiol Assay Kit (Electrochemiluminescence Reduction) / (Estradiol II); Estradiol Assay Kit (Electrochemiluminescence Reduction) / (Estradiol III) by Roche Diagnostics GmbH published August 30, 2016. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Estrad

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its estradiol detection kit (electrochemiluminescence assay).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2016-08-30
- Product Name: Estradiol Assay Kit (Electrochemiluminescence Reduction) / (Estradiol II); Estradiol Assay Kit (Electrochemiluminescence Reduction) / (Estradiol III)
- Recall Level: Level 2 Recall
- Recall Reason: Roche headquarters investigations have revealed that seversetron may cross-react with estradiol assay kits (electrochemiluminescence immunoassay) (Estradiol II and Estradiol III), leading to falsely elevated estradiol levels. Therefore, estradiol assay kits (electrochemiluminescence immunoassay) (Estradiol II and Estradiol III) should not be used to assess estradiol levels in patients receiving seversetron treatment. Further information will be added to the "Interference - Limitations" section of the product information leaflet.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Estradiol Detection Kits (Electrochemiluminescence Imaging), specifically models Estradiol II and Estradiol III. Publicly reported by the National Medical Products Administration (NMPA) on August 30, 2016, the company's internal report on June 21, 2016, highlighted a critical issue. It was discovered that fulvestrant, a medication, may cross-react with the estradiol detection kits, leading to falsely elevated estradiol test results. This could result in inaccurate patient diagnoses or inappropriate treatment decisions. Consequently, the affected kits must not be used for patients receiving fulvestrant treatment. Roche Diagnostics is implementing several corrective actions: sending urgent notification letters to customers about the issue and necessary precautions, and updating the product information leaflet to include warnings about this interference in the "Interference - Limitations" section. At the time of the report, Roche Diagnostics confirmed no complaints related to this specific issue had been received globally or in China, emphasizing the proactive nature of this recall to ensure product safety and accurate clinical results.

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