China NMPA Product Recall - Phenytoin assay dry slides (immunorate rate method)

The National Medical Products Administration (NMPA) issued a report on July 14, 2017, concerning a voluntary Class II recall initiated by Ausendo Medical Devices Trading (China) Co., Ltd. This recall pertains to their Phenytoin Assay Dry Tablets (Immunometry), identified under Registration No.: 20152402811. The primary issue prompting this action is the discovery of a potential negative bias during the testing of citrate plasma samples. This defect suggests that the product may yield inaccurately low results for phenytoin levels, which could have serious implications for patient management and therapeutic drug monitoring. Operating under the NMPA's stringent regulatory framework for medical devices, Ausendo Medical Devices Trading (China) Co., Ltd. is taking proactive steps to address this quality concern. The required action is a voluntary recall across specific models, specifications, and batch numbers of the affected product, with comprehensive details provided in the 'Medical Device Recall Event Report Form'. While no inspection dates are specified in the provided document, the company's initiation of this Class II recall demonstrates compliance with regulatory expectations to correct identified product deficiencies, thereby protecting public health and maintaining confidence in medical diagnostic tools.