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

Source: https://www.keypedia.com/records/china_product_recall/beckman-coulter-trading-china-co-ltd/39a7a4e5-483f-48cd-a6c2-fd7d31ce02fc
Source feed: China

> China NMPA product recall for Fully Automated Urine Chemical Analysis System by Beckman Coulter Trading (China) Co., Ltd. published April 06, 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: 2017-04-06
- Product Name: Fully Automated Urine Chemical Analysis System
- Recall Level: Level III
- Recall Reason: Iris International has determined that if the 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. The company identified that the sample needle position on affected products could be inaccurate or bent, potentially leading to insufficient sample volume on chemical test strips and a small probability of false negative results. This critical issue, which could compromise diagnostic accuracy, was discovered following user feedback regarding failed quality control testing. Operating under the oversight of the National Medical Products Administration (NMPA) in China, Beckman Coulter has implemented several corrective actions. These include sending direct communications to all affected customers and developing a Corrective Action (MOD) plan to upgrade existing systems. The company is committed to regularly reporting its progress on these measures to the Shanghai Drug Administration, ensuring regulatory compliance and safeguarding patient care. The recall involves multiple product models and specifications, with 138 units sold in China, reflecting a global scope for the affected devices.

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