# 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/d41d3ec8-d9e6-454d-9059-438441cf4e7e/
Source feed: China

> China NMPA product recall for Blood gas, blood oxygen, electrolyte and metabolite analyzer by Radiometer Medical Equipment (Shanghai) Co., Ltd. published March 02, 2020. Recall level: Level 3. Radomet Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall for 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: 2020-03-02
- Product Name: Blood gas, blood oxygen, electrolyte and metabolite analyzer
- Recall Level: Level 3
- Recall Reason: When blood gas, blood oxygen, electrolyte, and metabolite analyzers and their scanners are in normal use, users may use barcodes without a check digit, which may pose a potential risk of misreading. In rare cases, this could lead to patient confusion or delays in medical treatment.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: Radomet Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its blood gas, blood oxygen, electrolyte, and metabolite analyzers, identified by Registration Certificate No. 20192221680. The recall, published on March 2, 2020, addresses a critical issue where the analyzers' scanners may misread barcodes lacking a check digit during normal operation. This defect poses a risk of inaccurate data capture, potentially leading to patient confusion or delays in medical treatment. The regulatory framework for this action falls under the National Medical Products Administration (NMPA), with an index number of JGXX-2020-10117, indicating oversight by the Shanghai Municipal Drug Administration. While specific inspection dates are not detailed, the recall is a company-initiated action to mitigate patient safety risks. The required action for Radomet Medical Devices (Shanghai) Co., Ltd. is the full recall of all affected models, specifications, and serial numbers of the analyzers, with detailed information available in the accompanying Medical Device Recall Event Report Form. This measure aims to prevent potential patient harm resulting from data integrity issues with the medical devices.

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