# China NMPA Product Recall - Urine analysis test strips

Source: https://www.globalkeysolutions.net/records/china_product_recall/iris-deutschland-gmbh/c5fccf35-543b-4b61-8582-1707ed4db1b9/
Source feed: China

> China NMPA product recall for Urine analysis test strips by Iris Deutschland GmbH published August 24, 2015. Recall level: Level III. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Urine Analys

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary recall of urine analysis test strips.
- Company Name: Iris Deutschland GmbH
- Publication Date: 2015-08-24
- Product Name: Urine analysis test strips
- Recall Level: Level III
- Recall Reason: The iChemVELOCITY analyzer cannot maintain the 10-day in-machine stability period of the test strips described on the product label at temperatures of 18-28°C and relative humidity of 20-80%, thus affecting the test results.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Iris Deutschland GmbH
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Urine Analysis Test Strips, models 800-7204 and 800-7204-001. This action, reported to the National Medical Products Administration (NMPA) on August 24, 2015, was prompted by a critical issue with the iChemVELOCITY analyzer. The company determined that the analyzer could not maintain the stated 10-day stability period for the test strips as described on the product label, specifically under specified temperature and humidity conditions of 18-28℃ and 20-80% relative humidity. This technical deficiency directly impacts the reliability of test results for various urine analytes. As immediate corrective actions, Beckman Coulter has informed affected customers about the problem, advising them to continue using the product strictly according to existing operating procedures. Furthermore, the company is actively researching and developing a long-term solution to address the stability issue, with plans to notify users once a permanent resolution is available. This recall underscores the company's commitment to product performance under NMPA regulatory guidelines.

Company: https://www.globalkeysolutions.net/companies/iris-deutschland-gmbh/3e554cf1-70a1-4d87-8562-9bb7ae500f5b/