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

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/31a1454f-3653-4d4c-966e-2416263dd832/
Source feed: China

> China NMPA product recall for Glycated Hemoglobin A1c Assay Kit (HPLC Method) by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 3 Recall. Bio-Rad Life Sciences (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its Glycat

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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: 2018-12-05
- Product Name: Glycated Hemoglobin A1c Assay Kit (HPLC Method)
- Recall Level: Level 3 Recall
- Recall Reason: It is possible that 91 boxes of glycated hemoglobin A1c test kits were filled with incorrect calibrators, or that calibrators from the hemoglobin A2/hemoglobin F combined test kit (HPLC method) were mistakenly packaged into the glycated hemoglobin A1c test kits.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: Bio-Rad Life Sciences (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its Glycated Hemoglobin A1c Detection Kit (HPLC Method). This action, announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on December 5, 2018, addresses a critical packaging error. The primary issue involves approximately 91 boxes of the affected detection kits, which were found to contain incorrect calibrators. Specifically, calibrators intended for the Hemoglobin A2/Hemoglobin F Combined Detection Kit (HPLC Method) were mistakenly packaged into the Glycated Hemoglobin A1c kits. This mispackaging could lead to inaccurate test results, potentially impacting patient diagnosis and treatment. The recall covers specific product batches and specifications, detailed in an attached Medical Device Recall Event Report Form. Bio-Rad Life Sciences (Shanghai) Co., Ltd. is undertaking this recall to ensure compliance with medical device regulations and uphold product quality and patient safety standards, demonstrating a commitment to rectifying product discrepancies proactively.

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