# China NMPA Product Recall - ABL80 FLEX Blood Gas Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/radiometer-medical-equipment-shanghai-co-ltd/07635d81-3c86-415a-b5a3-91415f3ff842/
Source feed: China

> China NMPA product recall for ABL80 FLEX Blood Gas Analyzer by Radiometer Medical Equipment (Shanghai) Co., Ltd. published June 03, 2020. Recall level: Level 2. Redormet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Blood 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radomet Medical Equipment (Shanghai) Co., Ltd. is voluntarily recalling its ABL80 FLEX System blood gas analyzer.
- Company Name: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2020-06-03
- Product Name: ABL80 FLEX Blood Gas Analyzer
- Recall Level: Level 2
- Recall Reason: When blood gas analyzers and their barcode readers read unclear patient ID barcodes, there is a potential risk of misreading if the user uses a self-printed barcode type without a check digit. In extreme cases, this could lead to patient confusion or delays in medical treatment.
- Discovering Company: Radomet Medical Equipment Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: Redormet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Blood Gas Analyzer ABL80 FLEX System, as announced on June 3, 2020. The recall stems from a identified safety concern where the device may misread patient identification barcodes, particularly self-printed ones lacking check digits. This issue poses a potential risk of patient confusion or delays in crucial medical treatment. The National Medical Products Administration (NMPA) oversees this regulatory action, with specific details regarding affected product models and batches available in the accompanying "Medical Device Recall Event Report Form." This proactive measure by Redormet Medical Equipment aims to mitigate potential patient safety risks associated with barcode misinterpretation, ensuring compliance with medical device regulations enforced by authorities like the Shanghai Municipal Drug Administration.

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