# China NMPA Product Recall - Fully Automated Urine Chemical Analysis System

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/15bdcfca-d983-448c-be3e-3acfe90a7b24/
Source feed: China

> China NMPA product recall for Fully Automated Urine Chemical Analysis System by Beckman Coulter Trading (China) Co., Ltd. published March 17, 2017. Recall level: Level III. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Fully Automa

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. voluntarily recalls fully automated urine chemical analysis systems.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2017-03-17
- Product Name: Fully Automated Urine Chemical Analysis System
- Recall Level: Level III
- Recall Reason: Iris International has determined that if the sample needle in the iChem VELOCITY fully automated urine chemistry analysis system is misaligned or bent, it may result in insufficient sample application on the chemical test strips, leading to a very small probability of false negative results. This investigation was initiated based on user feedback regarding failed quality control tests.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Fully Automated Urine Chemical Analysis System (multiple models, e.g., 800-3530, 800-7167) following a report on February 14, 2017. The recall was prompted by the discovery that the system's sample needle could be inaccurately positioned or bent. This critical issue potentially leads to insufficient urine sample application onto the chemical test strips, thereby risking false negative results for various diagnostic parameters like glucose, protein, and blood. The problem was initially identified through user feedback concerning failures in quality control product testing. Operating under the oversight of the National Medical Products Administration (NMPA) of China, Beckman Coulter has undertaken several corrective actions. These include directly notifying affected customers through user letters and releasing a Corrective Action (MOD) brief for the urine chemistry analysis system. The company has also commenced upgrades for existing users to rectify the needle positioning issue. Furthermore, Beckman Coulter is committed to providing regular progress reports to the Shanghai Drug Administration to ensure full compliance and resolution of the recall.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad/