# China NMPA Product Recall - AQT90 FLEX Analyzer, a fully automated fluorescence immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/radiometer-medical-equipment-shanghai-co-ltd/715bb2b9-d3d8-476c-92d6-94a1e976bddf/
Source feed: China

> China NMPA product recall for AQT90 FLEX Analyzer, a fully automated fluorescence immunoassay analyzer by Radiometer Medical Equipment (Shanghai) Co., Ltd. published January 19, 2021. Recall level: Level 3 Recall. Redormet Medical Equipment (Shanghai) Co., Ltd. announced a voluntary Level III recall update for it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radomet Medical Equipment (Shanghai) Co., Ltd. is voluntarily recalling its AQT90 FLEX fully automated fluorescence immunoassay analyzer.
- Company Name: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2021-01-19
- Product Name: AQT90 FLEX Analyzer, a fully automated fluorescence immunoassay analyzer
- Recall Level: Level 3 Recall
- Recall Reason: The BIOS software of the E3800 CPU unit has a problem.
- Discovering Company: Radomet Medical Equipment Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: Redormet Medical Equipment (Shanghai) Co., Ltd. announced a voluntary Level III recall update for its AQT90 FLEX Analyzer, an Automated Fluorescence Immunoassay Analyzer, as documented by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. This update, dated January 19, 2021, refers to an original recall, Shanghai Drug Administration Medical Device Recall No. 2020-244. The core issue involves a problem with the E3800 CPU unit, for which Redormet has released a BIOS software update. This software update is a temporary resolution, and the company is actively investigating a permanent solution. The AQT90 FLEX Analyzer is regulated under Registration Certificate No. 国械注进20182222550. Redormet's required actions include providing the temporary software fix and continuing development for a final solution to ensure product reliability and safety. Detailed information on affected products is available in the associated Medical Device Recall Event Report Form.

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