# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.keypedia.com/records/china_product_recall/thermo-fisher-scientific-oy/465f84ad-e604-4563-979a-a6e700e91aca
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Thermo Fisher Scientific Oy published May 16, 2014. Recall level: . The National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2014-1

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: The Finnish company THERMO FISHER SCIENTIFICOY Clinical Diagnostics Finland has issued a recall for its fully automated sample processing system.
- Company Name: Thermo Fisher Scientific Oy
- Publication Date: 2014-05-16
- Product Name: Fully automated sample processing system
- Recall Reason: The manufacturer has issued a recall for its fully automated sample processing system, specifically TCAutomation software versions V2.6 and V3.2, and parallel bypass modules TCA Advia Centaur and Abbott Architect™, VITROS®, and/or Tosoh AIA@ software version V3.5. The recall is due to a potential delay in patient sample testing results and reporting. An investigation has confirmed that due to a software timing issue, sample carriers released in the bypass module may not be detected, thus potentially causing subsequent samples awaiting testing to be processed without priority. No error messages are displayed. The bypass module will indefinitely halt sample processing until an operator detects and intervenes. This issue is more likely to occur when using a Dell OptiPlex 790 LAS computer with time-saving enabled in the BIOS settings.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Thermo Fisher Scientific Oy
- Summary: The National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2014-10060) on May 16, 2014, regarding a voluntary global recall initiated by THERMO FISHER SCIENTIFIC OY Clinical Diagnostics Finland. The recall concerns their Fully Automated Sample Processing System (CFDA (Imported) No. 20131404786), distributed in China by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. Johnson & Johnson reported the recall on May 8, 2014.

Company: https://www.keypedia.com/companies/thermo-fisher-scientific-oy/6fc59fc8-1982-4b50-9d31-3d48c1d34b4b