# China NMPA Product Recall - Human thyroid-stimulating hormone calibrator, ferritin follicle-forming hormone calibrator, thyroglobulin antibody assay kit (chemiluminescence method), staining solutions for blood cell analysis

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/8df808f1-fbd7-44e5-8e23-6a80789b482e/
Source feed: China

> China NMPA product recall for Human thyroid-stimulating hormone calibrator, ferritin follicle-forming hormone calibrator, thyroglobulin antibody assay kit (chemiluminescence method), staining solutions for blood cell analysis by Beckman Coulter Trading (China) Co., Ltd. published July 14, 2017. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of several medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has voluntarily recalled products including human thyroid-stimulating hormone calibrators.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Human thyroid-stimulating hormone calibrator, ferritin follicle-forming hormone calibrator, thyroglobulin antibody assay kit (chemiluminescence method), staining solutions for blood cell analysis
- Recall Level: Level 3 Recall
- Recall Reason: The registration certificate information in the Chinese label is incorrect.
- 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 several medical devices, as reported by the National Medical Products Administration (NMPA) on July 14, 2017. The primary reason for this recall was incorrect registration certificate information displayed on the Chinese labels of the affected products. While specific inspection dates are not detailed within this NMPA document, the company's action falls under the regulatory framework of the National Medical Products Administration.

The recalled items include Human Thyroid Stimulating Hormone Calibrators, Ferritin Calibrators, Follicle-Stimulating Hormone Calibrators, Thyroglobulin Antibody Assay Kits (chemiluminescence method), and Staining Solutions for Blood Cell Analysis. The document specifies various registration numbers associated with these products, such as 20162404039, 20162404040, 20162404047, 20162404041, and 20161505. Beckman Coulter Trading (China) Co., Ltd. is undertaking this recall to address the labeling inaccuracy and ensure compliance. The company is expected to provide detailed information on specific models, specifications, and batches through a 'Medical Device Recall Event Report Form,' outlining the required actions for the recall process.

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