# China NMPA Product Recall - Human thyroid-stimulating hormone calibrator, ferritin calibrator, follicle-stimulating 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/61dac695-c52e-4668-9be8-abb84c3cb340/
Source feed: China

> China NMPA product recall for Human thyroid-stimulating hormone calibrator, ferritin calibrator, follicle-stimulating hormone calibrator, thyroglobulin antibody assay kit (chemiluminescence method), staining solutions for blood cell analysis by Beckman Coulter Trading (China) Co., Ltd. published July 19, 2017. Recall level: Level 3. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall, reported on June 2

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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: 2017-07-19
- Product Name: Human thyroid-stimulating hormone calibrator, ferritin calibrator, follicle-stimulating hormone calibrator, thyroglobulin antibody assay kit (chemiluminescence method), staining solutions for blood cell analysis
- Recall Level: Level 3
- Recall Reason: The registration certificate information on the Chinese label 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 Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall, reported on June 26, 2017, and officially published by the National Medical Products Administration (NMPA) on July 19, 2017. The recall involved several medical devices, including 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 main issue identified was that the registration certificate information on the Chinese labels of these products was incorrect and inconsistent with the NMPA
































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































Description: This decision (ruling) involves the effect of the listed sections, whose terms require, by their own terms, that they apply to the subject matter described. This regulatory text includes the amendments to parts 11, 21, 26, 81, 100, 101, 106, 107, 108, 109, 110, 111, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 133, 135, 136, 137, 139, 140, 142, 144, 145, 146, 147, 149, 150, 152, 155, 156, 158, 160, 161, 163, 164, 165, 166, 168, 169, 170, 172, 173, 175, 176, 177, 178, 179, 180, 181, 182, 184, 186, 189, 190, 200, 201, 202, 203, 206, 207, 210, 211, 212, 216, 225, 226, 250, 310, 312, 314, 315, 316, 320, 328, 329, 330, 331, 332, 333, 335, 336, 338, 339, 340, 341, 343, 344, 345, 346, 347, 348, 349, 352, 355, 357, 358, 361, 369, 431, 500, 501, 507, 508, 509, 510, 511, 514, 515, 520, 522, 524, 529, 530, 556, 558, 570, 571, 573, 579, 582, 584, 589, 600, 601, 606, 607, 610, 640, 660, 680, 700, 701, 710, 720, 740, 800, 801, 803, 806, 807, 808, 809, 812, 814, 820, 821, 860, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, 892, 895, 898, 900, 1000, 1002, 1003, 1010, 1020, 1030, 1040, 1050, 1250, 1271, and 1274 of title 21 of the Code of Federal Regulations. The purpose of these amendments is to modernize and streamline various provisions, remove outdated or redundant requirements, clarify existing regulations, and generally improve the efficiency and effectiveness of the regulatory framework administered by the FDA. These changes aim to reduce the burden on regulated industries while maintaining public health and safety standards.

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