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

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Alpha-Fetoprotein Assay Kits (Time-Resolved Fluorescence Assay), specifically batch number 652613, as reported on February 10, 2017, and published by the National Medical Products Administration (NMPA) on March 17, 2017. The recall pertains to a manufacturing defect discovered in the barcodes of the alpha-fetoprotein test pens (batch 652056) included in the kits. This printing flaw prevents the DELFIA Xpress Automated Time-Resolved Fluorescence Immunoassay Analyzer from recognizing the test pen barcodes, thereby inhibiting the performance of hAFP tests. While the defect poses a risk of delayed screening results, the company assessed the health hazard as minor. In response to this issue, which impacts 12 boxes sold in China and globally, PerkinElmer has outlined two corrective actions for affected users. Customers can receive corrected barcode labels for the defective test pens, along with instructions for application, or, alternatively, request replacement kits if they possess other unused AFP test kits in stock. This proactive recall demonstrates the company's commitment to product quality and patient safety, aligning with NMPA's medical device oversight.