# China NMPA Product Recall - Follicle-stimulating hormone (FSH) assay kit (chemiluminescence method), FSH calibrator, Total human chorionic gonadotropin (hCG) B subunit II calibrator (chemiluminescence method), Total human chorionic gonadotropin (hCG) subunit I assay kit (chemiluminescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/6e8c764e-4f36-4b81-81cd-03361eb22bc6/
Source feed: China

> China NMPA product recall for Follicle-stimulating hormone (FSH) assay kit (chemiluminescence method), FSH calibrator, Total human chorionic gonadotropin (hCG) B subunit II calibrator (chemiluminescence method), Total human chorionic gonadotropin (hCG) subunit I assay kit (chemiluminescence method) by Ortho-Clinical Diagnostics, Inc. published August 29, 2016. Recall level: Level III. Ausendo Medical Devices Trading (China) Co., Ltd., representing manufacturer Ortho-Clinical Diagnost

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling the following products: Follicle-stimulating hormone (FSH) assay kit (chemiluminescence method), FSH calibrators, Total Human Chorionic Gonadotropin (HCG) β Subunit II calibrators (chemiluminescence method), and Total Human Chorionic Gonadotropin (HCG) β Subunit II assay kit (chemiluminescence method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2016-08-29
- Product Name: Follicle-stimulating hormone (FSH) assay kit (chemiluminescence method), FSH calibrator, Total human chorionic gonadotropin (hCG) B subunit II calibrator (chemiluminescence method), Total human chorionic gonadotropin (hCG) subunit I assay kit (chemiluminescence method)
- Recall Level: Level III
- Recall Reason: Due to changes to the product registration certificate, specifically a change in the manufacturer's registered address (not the production address) and the change of the Chinese agent, the product's identification information is inconsistent with the registration certificate information.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., representing manufacturer Ortho-Clinical Diagnostics, initiated a voluntary Level III recall of several medical devices in China. This recall, reported to the National Medical Products Administration (NMPA) on June 6, 2016, and officially published on August 29, 2016, primarily impacts Follicle-Stimulating Hormone Assay Kits, Follicle-Stimulating Hormone Calibrators, Total Human Chorionic Gonadotropin B Subunit Calibrators, and Total Human Chorionic Gonadotropin B Subunit Assay Kits (all utilizing chemiluminescence methods). The main issue identified was a critical inconsistency between the products' identification information and their official NMPA registration certificates. This discrepancy arose from unreflected changes in the manufacturer's registered administrative address (distinct from the production facility) and the designated Chinese agent. Consequently, the products' labeling no longer aligned with the current regulatory documentation. To address this, Ausendo Medical Devices Trading (China) Co., Ltd. was required to inform all affected distributors and hospital clients about the discrepancy and implement corrective actions for all unused products remaining in their inventory. This ensures compliance with NMPA's regulatory framework and accurate product representation in the market.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/