# China NMPA Product Recall - Multi-channel sample feeding machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/diken-shanghai-trading-co-ltd/2145479c-d138-44f4-bbb7-547eb808dfd0/
Source feed: China

> China NMPA product recall for Multi-channel sample feeding machine by Diken (Shanghai) Trading Co., Ltd. published September 16, 2019. Recall level: Level 2 Recall. On September 16, 2019, the National Medical Products Administration (NMPA) announced that Diken (Sha

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Diken (Shanghai) Trading Co., Ltd. has initiated a voluntary recall of its multi-channel sample preparation machine.
- Company Name: Diken (Shanghai) Trading Co., Ltd.
- Publication Date: 2019-09-16
- Product Name: Multi-channel sample feeding machine
- Recall Level: Level 2 Recall
- Recall Reason: As the gas spring ages, when the instrument is equipped with an adjustable front cover and dust cover, the spring may lose resistance, causing the front panel to detach from its upright position and fall, or to be in a partially open position. The operator may be hit by the falling front panel, resulting in minor or moderate injury.
- Discovering Company: Diken (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Diken (Shanghai) Trading Co., Ltd.
- Summary: On September 16, 2019, the National Medical Products Administration (NMPA) announced that Diken (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its multi-channel plugging machine. The recall stems from a significant safety concern identified with the device's adjustable front cover and dust cover.
The primary issue involves the aging of the gas spring mechanism, which is designed to support these covers. Over time, the gas spring can lose its resistance, leading to the front panel detaching from its upright position, falling, or remaining partially open. This malfunction presents a clear risk of minor to moderate injury for operators who could be struck by the falling panel.
Operating under the oversight of the NMPA, which previously granted the device regulatory approval (CFDA (Imported) 2005 No. 2401579), Diken (Shanghai) Trading Co., Ltd. proactively took this corrective action. The company is required to manage the recall process, with specific details concerning affected models, specifications, and batch numbers outlined in a supplementary Medical Device Recall Event Report Form. This recall highlights the manufacturer's responsibility to address design-related safety deficiencies in medical devices to protect users.

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