The Food and Drug Administration warned that the three major medical giants recalled the same molecular diagnostic product!
Note that the Shanghai Food and Drug Administration has issued warnings for the same medical device products, and the three giants of Roche, Orson and Meili have recalled this product! On August 19th, the Shanghai Food and Drug Administration issued a regulatory notice on its website entitled “Contrary to the Estradiol Test Kit for Receiving the Risk of Detection and Diagnosis of Patients Treated with Fulvestrantâ€. “Recently, our bureau has received reports of medical device recalls from Roche Diagnostics Products (Shanghai) Co., Ltd. and Mérieux Diagnostics Products (Shanghai) Co., Ltd. to actively recall the estradiol test kit. The two companies found that due to fluorine Fulvestrant is similar in structure to estradiol and may cross-react with estradiol test kits. Therefore, when estradiol is detected in patients receiving fulvestrant, estradiol test results are false. This may lead to misleading doctors to change or stop using fulvestrant to continue treatment, which affects the patient's condition. The two companies warned that it is not recommended to use estradiol test kits for patients treated with fulvestrant. Test. Currently, the two companies have not received similar complaints on a global scale. The Shanghai Food and Drug Administration is cautious: pay attention to the risk of estradiol test kits for the diagnosis and treatment of patients treated with fulvestrant. The Shanghai Food and Drug Administration requires enterprises to strengthen the monitoring of medical device risks after listing, take effective measures, and actively recall medical devices with unreasonable risks. †The three giants have issued recall notices The Shanghai Food and Drug Administration mentioned in its announcement that it had received a voluntary recall report from Roche Diagnostics and Mérieux Diagnostics. However, according to Cypress's equipment, Ossendo is also the one that reports the proactive recall. On June 21, Roche Diagnostics (Shanghai) Co., Ltd. first reported that the registration certificate number is the estradiol test kit (electrochemiluminescence method) of the National Food and Drug Administration (Jin) 2012 No. 2402052 / ( Estradiol II) (China has now been delisted), and the Estradiol III product with the registration number of Guojiao into 20152403515 was actively recalled. Among them, the former sold 192,150 boxes in China, and the latter sold 23,873 boxes in China. On July 25th, Riès Diagnostics Products (Shanghai) Co., Ltd. issued a report on the active recall of the estradiol test kit (enzyme-linked fluorescence method) with the registration number of Guoquan injection into 20162401712. The relevant product number is 30431. China sold 1300 boxes. YT-H706 YT-H706 Shenzhen Sunshine Technology Co.,Ltd , https://www.szyatwin.com
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