# China NMPA Product Recall - Glycated Hemoglobin A1c Detection Kit (HPLC Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/ffde440f-b529-4856-87aa-e447fe525754/
Source feed: China

> China NMPA product recall for Glycated Hemoglobin A1c Detection Kit (HPLC Method) by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published April 17, 2019. Recall level: Level 3 Recall. On April 17, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. is voluntarily recalling its Glycated Hemoglobin A1c Detection Kit (HPLC Method).
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2019-04-17
- Product Name: Glycated Hemoglobin A1c Detection Kit (HPLC Method)
- Recall Level: Level 3 Recall
- Recall Reason: The product in question should contain two bottles of Cleaning Buffer 1 and one bottle of Cleaning Buffer. The quantity of Cleaning Buffer in the two reagent boxes does not match the registration information. The first box contains three bottles of Cleaning Buffer 2, but no Cleaning Buffer 1. The second box contains one bottle of Cleaning Buffer 1 and two bottles of Cleaning Buffer 2.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: On April 17, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Glycated Hemoglobin A1c Detection Kit (HPLC Method), registered under Certificate No. 20172402233. This action was reported to the Shanghai Food and Drug Administration, operating under the National Medical Products Administration (NMPA) framework in China.The recall was prompted by significant discrepancies in the product's cleaning buffer components compared to its officially registered specifications. Specifically, two distinct kit configurations were identified with incorrect contents. One kit was found to contain three bottles of cleaning buffer 2 but completely lacked cleaning buffer 1, diverging from the approved composition of two bottles of cleaning buffer 1 and one bottle of cleaning buffer 2. A second affected kit contained one bottle of washing buffer 1 and two bottles of washing buffer 2, again not conforming to the registered component quantities.These packaging inconsistencies indicate that the kits were not assembled according to their officially documented and approved configurations. As a direct consequence of these manufacturing and packaging deviations, Bio-Rad Life Sciences (Shanghai) Co., Ltd. is taking the required action to remove the non-conforming products from the market. Further specific details regarding the affected product models, specifications, and batch numbers are provided in the accompanying Medical Device Recall Event Report Form.

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