# China NMPA Product Recall - Sex hormone-binding globulin calibrators, sex hormone-binding globulin control products

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/7fb5e21f-9d0c-422e-8aa2-821a07f85bdd/
Source feed: China

> China NMPA product recall for Sex hormone-binding globulin calibrators, sex hormone-binding globulin control products by Beckman Coulter Trading (China) Co., Ltd. published February 28, 2019. Recall level: Level 3 Recall. On February 28, 2019, the National Medical Products Administration (NMPA) published a recall notice 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling sex hormone-binding globulin calibrators and sex hormone-binding globulin control products.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-02-28
- Product Name: Sex hormone-binding globulin calibrators, sex hormone-binding globulin control products
- Recall Level: Level 3 Recall
- Recall Reason: The products in question, according to Beckman Coulter's quality system requirements for product stability, have labels indicating an 18-month shelf life for the sex hormone-binding globulin calibrator (A48618) and sex hormone-binding globulin control (A48619), while the registered shelf life for both products in China is 12 months. This issue does not affect the test results.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: On February 28, 2019, the National Medical Products Administration (NMPA) published a recall notice concerning products from Beckman Coulter Trading (China) Co., Ltd. The recall specifically involves the Sex Hormone-Binding Globulin Calibrator (A48618) and Sex Hormone-Binding Globulin Control Product (A48619). The core issue identified was a discrepancy between the product labels, which indicated an 18-month shelf life, and the officially registered shelf life of 12 months for these products within China. Beckman Coulter initiated a voluntary Class III recall of the affected calibrators and control products. The company clarified that, despite this labeling inconsistency, the issue does not affect the actual test results or the performance of the products. This action was taken in accordance with Beckman Coulter's internal quality system requirements for product stability and under the regulatory oversight of the NMPA and the Shanghai Food and Drug Administration. Detailed information regarding affected product models, specifications, and batches is available in a separate Medical Device Recall Event Report Form.

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