# 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/b2213ca0-c0fa-4194-a6cc-8821988ebec6/
Source feed: China

> China NMPA product recall for Blood gas, blood oxygen, electrolyte and metabolite analyzer by Radiometer Medical Equipment (Shanghai) Co., Ltd. published June 23, 2021. Recall level: Level 2 Recall. Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall, as updated on 

---

## 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: 2021-06-23
- Product Name: Blood gas, blood oxygen, electrolyte and metabolite analyzer
- Recall Level: Level 2 Recall
- Recall Reason: Unexplained power outage and timing issues caused by the E3800 CPU unit
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall, as updated on June 23, 2021, for its Blood Gas, Blood Oxygen, Electrolyte, and Metabolite Analyzers (Registration Certificate No.: 20192221680). This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a critical functionality issue.

The core problem identified is a "time issue" directly resulting from abnormal power outages affecting the E3800 CPU unit within the affected medical devices. This malfunction could potentially compromise the accuracy and reliability of diagnostic data generated by the analyzers.

To resolve this defect, Radomet Medical Equipment (Shanghai) Co., Ltd. is providing a software update, which has been designated as the definitive solution for this recall activity. The decision to maintain a Level II recall signifies that the malfunction could lead to temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Detailed information regarding specific affected product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" accessible through the NMPA's platform. This proactive recall demonstrates the company's commitment to product safety and compliance with national medical device regulations.

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