# China NMPA Product Recall - Interleukin-6 calibrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/4c5035ef-719a-478f-8a8c-64edc55b60ec/
Source feed: China

> China NMPA product recall for Interleukin-6 calibrator by Beckman Coulter Trading (China) Co., Ltd. published December 05, 2018. Recall level: Level 3 Recall. This document, published by the National Medical Products Administration (NMPA) on December 5, 2018,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. voluntarily recalls interleukin-6 calibrators.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Interleukin-6 calibrator
- Recall Level: Level 3 Recall
- Recall Reason: The interleukin-6 calibrator with batch number 724582 failed to meet the product's stated stability at 2-10℃ unopened. Using this batch may lead to quality control issues and disease outbreaks.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: This document, published by the National Medical Products Administration (NMPA) on December 5, 2018, details a voluntary Level III recall initiated by Beckman Coulter Trading (China) Co., Ltd. The recall pertains to their Interleukin-6 Calibrators, specifically batch number 724582 (Registration Certificate No.: 20152403254). The core issue identified was that the affected batch failed to meet its stated stability requirements when stored unopened at 2-10℃. This stability deviation poses a significant risk to quality control procedures and could potentially compromise patient diagnoses by leading to inaccurate test results. The company undertook this recall voluntarily, operating under the regulatory framework of the NMPA, specifically referenced as "Shanghai Food and Drug Administration Medical Device Recall 2018-272." As a required action, Beckman Coulter Trading (China) Co., Ltd. has commenced a Level III recall to remove the non-conforming Interleukin-6 Calibrators from circulation. Comprehensive details, including specific product models, specifications, and additional batch information, are provided in an accompanying "Medical Device Recall Event Report Form." This proactive measure is critical for safeguarding public health and maintaining the integrity of medical device quality standards.

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