China NMPA Product Recall - Fully Automated Fluorescence Immunoassay Analyzer

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Fully Automated Fluorescence Immunoassay Analyzer. The company identified a manufacturing defect in the sliding bearings of specific product batches. These bearings are susceptible to corrosion when exposed to humid environments over extended periods. Corrosion of these critical components could potentially impair the analyzer's performance and accuracy, posing a risk to diagnostic processes. The recall was publicly reported on March 17, 2017, under the oversight of the National Medical Products Administration (NMPA) in China. PerkinElmer has taken responsibility for the issue by recalling the affected units to mitigate any potential impact on patient diagnostics and maintain product quality standards. Detailed information regarding the models, specifications, and batch numbers involved was provided in an accompanying Medical Device Recall Event Report Form.