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

Source: https://www.keypedia.com/records/china_product_recall/cao-medical-equipment-co-ltd/b439a2d7-9341-4524-b1c6-a1c0508bc9a7
Source feed: China

> China NMPA product recall for Blood gas, blood oxygen, electrolyte and metabolite analyzer by CAO Medical Equipment Co., Ltd. published March 05, 2020. Recall level: Level 3 Recall. Radomet Medical Equipment (Shanghai) Co., Ltd. has issued an updated Class III voluntary recall for 

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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: CAO Medical Equipment Co., Ltd.
- Publication Date: 2020-03-05
- Product Name: Blood gas, blood oxygen, electrolyte and metabolite analyzer
- Recall Level: Level 3 Recall
- Recall Reason: Further investigation revealed that the hemolyzers in the previously recalled blood gas, blood oxygen, electrolyte, and metabolite analyzers had a measurement deviation in total bilirubin (tBil) for newborns that met product technical requirements. Therefore, no further special action was needed for instruments used in newborns. The recall strategy needs to be updated.
- Discovering Company: Radomet Medical Equipment Co., Ltd.
- Manufacturing Company: CAO Medical Equipment Co., Ltd.
- Summary: Radomet Medical Equipment (Shanghai) Co., Ltd. has issued an updated Class III voluntary recall for its Blood Gas, Blood Oxygen, Electrolyte and Metabolite Analyzers. Published by the National Medical Products Administration (NMPA) on March 5, 2020, this update amends the previous Shanghai Food and Drug Administration Medical Device Recall No. 2019-286. The initial concern stemmed from a perceived measurement deviation in total bilirubin (tBil) for newborns detected by the analyzers' hemolyzer. However, further investigation revealed that this specific deviation actually meets the product's technical requirements when used for newborns. Consequently, no special actions are now required for instruments utilized in newborn applications, necessitating a revision of the original recall strategy. The regulatory oversight for this action involves both the Shanghai Food and Drug Administration, which initiated the original recall, and the NMPA, responsible for the official announcement. Radomet Medical Equipment is required to update its recall strategy, with comprehensive details on affected product models, specifications, and batches provided in the accompanying Medical Device Recall Event Report Form.

Company: https://www.keypedia.com/companies/cao-medical-equipment-co-ltd/fffe5828-92d5-4225-8981-290c69ddadd7