# China NMPA Product Recall - Fully automated blood gas analyzer (GEM Premier 3000, 3500, 4000)

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/b68ac243-aae2-413d-bec8-0f86508a78b6/
Source feed: China

> China NMPA product recall for Fully automated blood gas analyzer (GEM Premier 3000, 3500, 4000) by Instrumentation Laboratory Co. published July 04, 2019. Recall level: Level 3 Recall. Instrumentation Laboratory Co., in collaboration with its agent Wofen Medical Devices Trading (Beiji

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Instrumentation Laboratory Co. has initiated a voluntary recall of its fully automated blood gas analyzers.
- Company Name: Instrumentation Laboratory Co.
- Publication Date: 2019-07-04
- Product Name: Fully automated blood gas analyzer (GEM Premier 3000, 3500, 4000)
- Recall Level: Level 3 Recall
- Recall Reason: GEM Premier 3000, 3500 and 4000 instruments manufactured within a period following the renewal of the registration certificate on 2018/02/27 have an old China NMPA registration certificate number on the Chinese label on the back.
- Discovering Company: Wofen Medical Equipment Trading (Beijing) Co., Ltd.
- Manufacturing Company: Instrumentation Laboratory Co.
- Summary: Instrumentation Laboratory Co., in collaboration with its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a Class III voluntary recall of its Fully Automated Blood Gas Analyzers in China. This recall, publicized by the National Medical Products Administration (NMPA) on July 4, 2019, affects GEM Premier 3000, 3500, and 4000 models manufactured after February 27, 2018. The primary issue concerns a labeling discrepancy: the Chinese label on the back of 558 affected units displayed an outdated NMPA registration certificate number, failing to meet current regulatory requirements. Operating under the NMPA's framework for medical device oversight, the company has prescribed specific corrective actions. Instrumentation Laboratory Co. is providing accurate supplementary labels. Wofen Medical Devices Trading (Beijing) Co., Ltd. is responsible for distributing field safety notices and these supplementary labels to all affected distributors. Furthermore, the agent must ensure all incorrect labels on products in their inventory and at customer locations are promptly updated with the correct NMPA registration information, thereby ensuring regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/instrumentation-laboratory-co/fe42e432-39e1-4428-9245-848558cb2c0a/