# China NMPA Product Recall - Urine analysis test strips (dry chemistry method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/73220112-a483-4570-9233-0022b8b6ec29
Source feed: China

> China NMPA product recall for Urine analysis test strips (dry chemistry method) by Beckman Coulter, Inc. published January 10, 2018. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a document on January 10, 2018, detail

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its urine analysis test strips (dry chemistry method).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2018-01-10
- Product Name: Urine analysis test strips (dry chemistry method)
- Recall Level: Level 3 Recall
- Recall Reason: A manufacturing error occurred when an incorrect test strip was unintentionally placed in the compensation pad position, potentially causing IRISpec CB quality control to fail and resulting in false negative results for all analytes except ascorbic acid.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: The National Medical Products Administration (NMPA) published a document on January 10, 2018, detailing a voluntary product recall initiated by Beckman Coulter, Inc. and its affiliate, Beckman Coulter Trading (China) Co., Ltd. The recall concerns urine analysis test strips (dry chemistry method) due to a manufacturing defect. Specifically, an incorrect test strip was inadvertently placed in the compensation pad position during production. This error poses a significant risk as it could compromise the test strip's performance, potentially leading to the failure of IRISpec CB quality control. More critically, the defect has the potential to produce false negative results for all analytes tested, with the sole exception of ascorbic acid. This could have serious implications for patient diagnosis and treatment decisions. In response to this issue, Beckman Coulter, Inc. has voluntarily initiated a Class III recall for the affected urine analysis test strips, identified under Registration Certificate No.: 20172402235. The company has committed to providing detailed information regarding specific affected product models, specifications, and batch numbers in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with NMPA regulations.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825