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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/b4e74277-a19e-4c09-a51b-9573e32daa8d/
Source feed: China

> China NMPA product recall for Human thyroid-stimulating hormone calibrators, ferritin calibrators, follicle-stimulating hormone calibrators, thyroglobulin antibody assay kits (chemiluminescence method), staining solutions for blood cell analysis by Beckman Coulter, Inc. published August 08, 2017. Recall level: Level 3. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level 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, Inc.
- Publication Date: 2017-08-08
- Product Name: Human thyroid-stimulating hormone calibrators, ferritin calibrators, follicle-stimulating hormone calibrators, thyroglobulin antibody assay kits (chemiluminescence method), staining solutions for blood cell analysis
- Recall Level: Level 3
- Recall Reason: The registration certificate information on the Chinese labels of the products listed above is inconsistent with the registration certificate information approved by the State Drug Administration.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall of several medical devices, as reported to the National Medical Products Administration (NMPA) on June 26, 2017, and published on August 8, 2017. This recall was not a result of an inspection but rather a company-identified issue. The main violation involved incorrect registration certificate information on the Chinese labels of the affected products, which was inconsistent with approvals from the State Food and Drug Administration. The products subject to recall include Human Thyroid Stimulating Hormone Calibrators, Ferritin Calibrators, Follicle Stimulating Hormone Calibrators, Globulin Antibody Assay Kits (Chemiluminescence Method), and Staining Solutions for Hematology Analysis. A total of 22,207 boxes across five product numbers and nine batch numbers were affected in China. In response, Beckman Coulter took immediate corrective actions. They notified all relevant customers through official letters. All existing inventory of affected products was relabeled with the correct registration certificate information. Subsequently, these correctly labeled products were shipped to clients. The company is mandated to submit a comprehensive summary report of these corrective actions to the Shanghai Municipal Food and Drug Administration once the relabeling process is complete for all affected items.

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