# China NMPA Product Recall - 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/platinum-elmer-medical-diagnostics-products-shanghai-co-ltd/6774cb31-7f6d-46ef-9010-713fbd3d319a/
Source feed: China

> China NMPA product recall for 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay) by Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. published July 14, 2017. Recall level: Level 3 Recall. Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its 17α-hydroxyprogesterone assay kit (time-resolved fluorescence method).
- Company Name: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay)
- Recall Level: Level 3 Recall
- Recall Reason: Product ingredient labeling error
- Discovering Company: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay) (Registration No.: 20153402061). This recall, reported by the company, addresses a critical error found in the labeling of product components. The National Medical Products Administration (NMPA) published this information on July 14, 2017, referencing index number JGXX-2017-10586. The company's proactive measure ensures compliance with regulatory standards by addressing the identified labeling discrepancy. Detailed information regarding affected models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This action underscores the company's commitment to product safety and regulatory adherence under the NMPA framework, requiring the immediate withdrawal of the affected kits from the market to mitigate any potential risks associated with mislabeled components.

Company: https://www.globalkeysolutions.net/companies/platinum-elmer-medical-diagnostics-products-shanghai-co-ltd/04fb6867-6d1f-485b-a064-5d8bc4b5ac61/