# China NMPA Product Recall - Alpha-fetoprotein (AFP) Assay Kit (Time-Resolved Fluorescence Assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/platinum-elmer-medical-diagnostics-products-shanghai-co-ltd/9d501cdf-8e9f-4226-a242-62ca1622cd9a/
Source feed: China

> China NMPA product recall for Alpha-fetoprotein (AFP) Assay Kit (Time-Resolved Fluorescence Assay) by Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. published March 17, 2017. Recall level: Level III. PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Alpha-Fetoprotein Assay Kit (Time-Resolved Fluorescence Assay).
- Company Name: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-03-17
- Product Name: Alpha-fetoprotein (AFP) Assay Kit (Time-Resolved Fluorescence Assay)
- Recall Level: Level III
- Recall Reason: The barcodes on the alpha-fetoprotein (AFP) test pens for products with batch numbers have printing defects, affecting the normal testing of the products.
- Discovering Company: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Alpha-Fetoprotein Assay Kits (Time-Resolved Fluorescence Assay), as announced by the National Medical Products Administration (NMPA) on March 17, 2017. The recall stemmed from a critical manufacturing issue: a printing defect discovered in the barcodes of the alpha-fetoprotein test pens within the affected product batches. This defect significantly impaired the normal testing functionality of the kits, rendering them unreliable for accurate diagnostic use.

The company proactively reported this issue and decided to recall the products to mitigate potential risks. The NMPA, operating under its regulatory framework for medical devices, published the recall notice, highlighting the company's required action to remove the faulty products from circulation. While specific inspection dates are not explicitly detailed in the public notice, the publication date marks the official announcement of the company's decision following their internal investigation. Further comprehensive details, including specific product models, specifications, and batch numbers, are documented in an accompanying "Medical Device Recall Event Report Form," ensuring a thorough resolution to the quality concern.

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