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

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its Alpha-Fetoprotein Assay Kits (Time-Resolved Fluorescence Assay) on February 10, 2017, as reported by the National Medical Products Administration (NMPA) on April 6, 2017. The recall pertains to product batch 652613, specifically affecting the alpha-fetoprotein test pens within those kits, which carry batch number 652056. The core issue identified was a printing defect in the barcodes of the test pens. This defect prevented the DELFIA Xpress Automated Time-Resolved Fluorescence Immunoassay Analyzer from recognizing the barcodes, consequently hindering the proper operation and testing of hAFP levels. While the defect primarily poses a risk of delaying screening results, the associated health hazard was deemed minor. Operating under the oversight of the NMPA, PerkinElmer has taken proactive steps to address this issue. For the 12 boxes of affected products sold in China, customers are offered two corrective measures. They can either receive corrected barcode stickers for the affected test pens, along with instructions for application, or they can request a full replacement of any unused defective kits with a new, compliant batch. This ensures continued accuracy and reliability for in vitro quantitative determination of alpha-fetoprotein in maternal serum and amniotic fluid.