China NMPA Product Recall - Alpha-fetoprotein Assay Kit (Time-Resolved Fluorescence Assay) DELFIA Xpress hAFP

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Alpha-Fetoprotein Assay Kits (Time-Resolved Fluorescence Assay) in February 2017, as documented by the National Medical Products Administration (NMPA) of China. The primary issue involved a printing defect on the barcodes of alpha-fetoprotein test pens (batch 652056), which are components of the kit (batch 652613). This defect rendered the DELFIA Xpress fully automated analyzer unable to recognize the test pens, thereby preventing diagnostic tests from running. While this issue posed a risk of delaying crucial screening result reporting, the associated health hazard was deemed relatively minor. Operating under NMPA guidelines, PerkinElmer proactively implemented corrective actions to address this product deficiency. These actions included providing customers with corrected barcodes for the affected test pens. Additionally, customers with unused defective kits in their inventory were offered replacements with new, compliant batches upon request. This recall highlights the company's commitment to product integrity and user safety within the regulatory framework governing medical devices in China.