China NMPA Product Recall - Fully Automated Time-Resolved Fluorescence Immunoassay System

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. has initiated a Class II voluntary recall of its Fully Automated Time-Resolved Fluorescence Immunoassay System (Model 1235), affecting 13 units sold in China. The recall was reported to the National Medical Products Administration (NMPA) on June 17, 2016, and publicly announced on August 30, 2016. The primary issue identified is a product defect where ambient light can enter the measurement unit if the instrument's front panel is open during specific testing phases. This light interference affects the measurement of samarium markers, particularly impacting B067-101 and B097-101 kits used for prenatal screening of Trisomy 21 (Down syndrome). The defect can lead to an increased samarium signal, resulting in a higher false positive rate for T21 screening. While the likelihood of harm, such as unnecessary confirmatory tests or medical interventions, is deemed "rare," the company is addressing the potential for erroneous screening results. As immediate actions, customers are instructed to ensure the instrument's front panel remains closed during test runs, particularly outside the incubation phase, and during dual-calibration procedures. Users are also advised to verify calibration values against kit specifications and contact PerkinElmer if discrepancies or prior affected calibrations occurred. The long-term resolution involves PerkinElmer developing and providing a free hardware modification and an updated patch package to permanently prevent ambient light interference.