# China NMPA Product Recall - Blood gas, blood oxygen, electrolyte and metabolite analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/radiometer-medical-equipment-shanghai-co-ltd/80071de6-8752-4ab2-a218-3700dc8ea5a8/
Source feed: China

> China NMPA product recall for Blood gas, blood oxygen, electrolyte and metabolite analyzer by Radiometer Medical Equipment (Shanghai) Co., Ltd. published April 02, 2021. Recall level: Level 2 Recall. Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Blood Ga

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radiometer Medical Equipment (Shanghai) Co., Ltd. is voluntarily recalling its blood gas, blood oxygen, electrolyte, and metabolite analyzers.
- Company Name: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2021-04-02
- Product Name: Blood gas, blood oxygen, electrolyte and metabolite analyzer
- Recall Level: Level 2 Recall
- Recall Reason: In cases involving the product's internal clock, there is a potential risk of measurement bias.
- Discovering Company: Radomet Medical Equipment Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Blood Gas, Blood Oxygen, Electrolyte and Metabolite Analyzers. This action, published on April 2, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a critical product issue. The recall stems from a potential risk of measurement deviation, specifically in rare instances where the product's internal clock may malfunction. The affected devices, identified under Registration Certificate No.: 国械注进20192221680, pose a concern regarding the accuracy of diagnostic measurements. While the document does not specify inspection dates, the regulatory oversight is clearly provided by the NMPA, indicating a structured response to ensure public health and safety. Radomet's proactive measure to voluntarily recall these analyzers demonstrates adherence to regulatory expectations for addressing product non-conformities. The Class II recall designation signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is required to provide detailed information on specific models, specifications, and batch numbers through a "Medical Device Recall Event Report Form" to facilitate the recall process and ensure all affected units are identified and managed appropriately. This ensures patient safety by removing potentially faulty diagnostic equipment from circulation.

Company: https://www.globalkeysolutions.net/companies/radiometer-medical-equipment-shanghai-co-ltd/f92b69f4-700c-4f10-b265-b088de493537/