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

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.