China NMPA Product Recall - D-dimer detection kit (dry immunochromatography)

On January 2, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class I recall initiated by Alere (Shanghai) Medical Device Sales Co., Ltd. The recall pertains to specific batches of their D-Dimer Detection Kit (Dry Immunochromatography), identified by Registration Certificate No.: 20142405787. This action was taken due to a critical performance issue where affected kits may yield D-Dimer results lower than the clinical cutoff level of 0.3 mg/L, even when other laboratory methods indicate levels above this threshold. This discrepancy presents a significant risk for potential misdiagnosis or delayed treatment, as patients requiring intervention might be incorrectly identified as having normal D-Dimer levels. Alere (Shanghai) Medical Device Sales Co., Ltd., acting on behalf of its parent company, Alere (Norway) Technologies AB, proactively reported this issue. The Class I designation signifies that the use of these defective products carries a reasonable probability of serious adverse health consequences or death. The recall mandates the company to retrieve all affected product models, specifications, and batches, with detailed information available in a comprehensive Medical Device Recall Event Report Form. This recall highlights the NMPA's stringent oversight and the manufacturer's responsibility in ensuring the safety and accuracy of medical diagnostic devices.