# China NMPA Product Recall - Glycated hemoglobin protein control

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/2b6d9cac-c420-454a-8f1c-13924353fadf/
Source feed: China

> China NMPA product recall for Glycated hemoglobin protein control by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published May 08, 2017. Recall level: Level III. On May 8, 2017, the National Medical Products Administration (NMPA) reported a voluntary Class III r

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. voluntarily recalls glycated hemoglobin protein control products.
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Glycated hemoglobin protein control
- Recall Level: Level III
- Recall Reason: During its shelf life, the hemoglobin A1C value may gradually decrease.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: On May 8, 2017, the National Medical Products Administration (NMPA) reported a voluntary Class III recall initiated by Bio-Rad Biomedical Products (Shanghai) Co., Ltd. The recall pertained to specific batches (38530 and 38540) of its glycated hemoglobin control products. The company discovered that the hemoglobin A1C value in these products might gradually decrease during their designated shelf life. This issue could compromise the accuracy and reliability of diagnostic results derived from these controls, which are vital for monitoring diabetes. While no specific inspection dates were provided, the recall was a proactive measure taken by Bio-Rad Biomedical Products (Shanghai) Co., Ltd. upon self-identification of the defect. The regulatory framework under the NMPA classified this as a Class III recall, indicating a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Required actions involved the company voluntarily initiating the recall, with detailed product information provided in a "Medical Device Recall Event Report Form," signaling adherence to established regulatory procedures for addressing product quality concerns.

Company: https://www.globalkeysolutions.net/companies/bio-ray-life-sciences-shanghai-co-ltd/2e5e555e-1d88-4064-97e3-120d5825f4ca/