China NMPA Product Recall - Troponin T test card (time-resolved immunofluorescence assay)

Radiometer Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall on December 2, 2019, concerning its Troponin T Test Cards (Time-Resolved Immunofluorescence Assay). The recall was prompted by the company's awareness that 11 boxes of these test cards, delivered to customers, featured incorrect Chinese box labels and instructions. Specifically, the mislabeling mistakenly identified the product as an "N-terminal B-type natriuretic peptide precursor test card (time-resolved immunofluorescence assay)" instead of the correct Troponin T designation. Despite the accurate labeling on the outer and inner boxes, correct product barcodes, and the analyzer's ability to identify the Troponin T test cards correctly, the erroneous Chinese instructions posed a potential compliance issue. The company is taking proactive measures to address this discrepancy, ensuring adherence to regulatory standards established by the National Medical Products Administration (NMPA) of China. This voluntary action underscores Radiometer's commitment to product integrity and regulatory compliance, particularly for products registered under certificate number 20162405276. Detailed information regarding affected product models, specifications, and batch numbers is available in the associated Medical Device Recall Event Report Form, accessible via the NMPA website. This recall ensures accurate representation of medical devices to prevent potential misinterpretation in clinical settings.