# China NMPA Product Recall - Fully automated blood typing analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/2fc41f51-029f-42be-95c9-d192d7de0ce4/
Source feed: China

> China NMPA product recall for Fully automated blood typing analyzer by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published April 18, 2019. Recall level: Level 3 Recall. On April 18, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. announced a voluntary Class III recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Ray Life Sciences (Shanghai) Co., Ltd. is voluntarily recalling its fully automated blood typing analyzer.
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2019-04-18
- Product Name: Fully automated blood typing analyzer
- Recall Level: Level 3 Recall
- Recall Reason: The product in question is an automated blood typing analyzer. During routine use, the software included with the analyzer was used with the Admin account of that software, which may cause delays in test results, but will not affect the interpretation of the results.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: On April 18, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. announced a voluntary Class III recall of its fully automated blood typing analyzer. This significant action was taken due to a recognized software issue identified during routine operation. Specifically, the use of the Admin account within the analyzer's installed software system has the potential to cause delays in the display or processing of test results. While the company assures that the ultimate interpretation of these results remains unaffected, the potential for operational delays necessitated this intervention to ensure optimal performance and user experience. The affected product is a medical device registered under Certificate No. 20163402578, originally granted by the Shanghai Food and Drug Administration. This recall process is managed under the oversight of the National Medical Products Administration (NMPA), the primary regulatory body responsible for medical devices in China. As part of this voluntary recall, Bio-Rad Life Sciences (Shanghai) Co., Ltd. is providing comprehensive details, including specific models, specifications, and batch numbers of all impacted analyzers, through a "Medical Device Recall Event Report Form." This proactive measure by Bio-Rad underscores its commitment to product quality and patient safety, addressing the identified software anomaly to prevent any potential disruption in diagnostic workflows. The recall serves to ensure that healthcare providers maintain confidence in the timely and accurate performance of their equipment.

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