# China NMPA Product Recall - Freedom EVO NAE Workstation, a fully automated enzyme immunoassay workstation and nucleic acid extraction and purification instrument.

Source: https://www.globalkeysolutions.net/records/china_product_recall/diken-shanghai-trading-co-ltd/2b2be3b1-8b6d-4754-be06-887997faa0bb/
Source feed: China

> China NMPA product recall for Freedom EVO NAE Workstation, a fully automated enzyme immunoassay workstation and nucleic acid extraction and purification instrument. by Diken (Shanghai) Trading Co., Ltd. published March 01, 2019. Recall level: Level 3 Recall. DIKEN (Shanghai) Trading Co., Ltd. has initiated a voluntary Class III recall for several of its aut

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Diken (Shanghai) Trading Co., Ltd. is voluntarily recalling its fully automated enzyme immunoassay workstations (Freedom EVO NAE Workstation) and fully automated nucleic acid extraction and purification instruments.
- Company Name: Diken (Shanghai) Trading Co., Ltd.
- Publication Date: 2019-03-01
- Product Name: Freedom EVO NAE Workstation, a fully automated enzyme immunoassay workstation and nucleic acid extraction and purification instrument.
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves a problem found in the software used by automated enzyme immunoassay workstations and fully automated nucleic acid extraction and purification instruments. This problem is related to a specific date parameter within the software.
- Discovering Company: Diken (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Diken (Shanghai) Trading Co., Ltd.
- Summary: DIKEN (Shanghai) Trading Co., Ltd. has initiated a voluntary Class III recall for several of its automated medical devices, specifically the fully automated enzyme immunoassay workstations and the fully automated nucleic acid extraction and purification instruments (Freedom EVO NAE Workstation). This recall was officially announced by the National Medical Products Administration (NMPA) on March 1, 2019. The fundamental issue prompting this action is a critical software malfunction identified in these instruments, linked to a specific date parameter within their operating software. This defect could potentially impact the reliable functioning of the devices. The regulatory framework for this action falls under the NMPA's medical device oversight, with the Shanghai Food and Drug Administration having issued relevant registration numbers, including 国械注进20172406573, 国食药监械（进）字2014第 2400032号, and 国械备20160221号. As a required action, DIKEN (Shanghai) Trading Co., Ltd. is actively recalling all affected product models, specifications, and batches to rectify this software problem, with detailed information provided in a "Medical Device Recall Event Report Form." This ensures product safety and adherence to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/diken-shanghai-trading-co-ltd/ec2f8763-bd95-482f-b4c6-aeec4773a553/