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

Source: https://www.globalkeysolutions.net/records/china_product_recall/cao-medical-equipment-co-ltd/018e63c3-6f56-4cdf-9a45-4af66a530a55/
Source feed: China

> China NMPA product recall for AQT90 FLEX Analyzer, a fully automated fluorescence immunoassay analyzer by CAO Medical Equipment Co., Ltd. published December 11, 2020. Recall level: Level 3 Recall. Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its AQT90 

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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: CAO Medical Equipment Co., Ltd.
- Publication Date: 2020-12-11
- Product Name: AQT90 FLEX Analyzer, a fully automated fluorescence immunoassay analyzer
- Recall Level: Level 3 Recall
- Recall Reason: The fully automated fluorescence immunoassay analyzer may trigger a time reset error when an incorrect power outage sequence occurs.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: CAO Medical Equipment Co., Ltd.
- Summary: Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its AQT90 FLEX Automated Fluorescence Immunoassay Analyzer. This action, reported on December 11, 2020, was publicly announced through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The company became aware that the analyzer may experience a "time reset error" if an incorrect power-off sequence is executed. This specific operational malfunction prompted the company to proactively recall affected devices to address the issue and maintain product integrity. The recall is detailed in NMPA Index No. JGXX-2020-10691 and Shanghai Drug Administration Recall No. 2020-244, with further specifics on product models, specifications, and batches available in the 

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