China NMPA Product Recall - Ammonia Assay Kit (Glutamate Dehydrogenase Method)

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of 13 medical devices, including their Ammonia Assay Kit (Glutamate Dehydrogenase Method). This action, published by the National Medical Products Administration (NMPA) on August 2, 2017, was prompted by concerns regarding test result interference. The company reported that the presence of sulfasalazine and sulfapyridine could compromise the accuracy of the products' assays. This issue necessitates a recall to ensure the reliability of diagnostic outcomes. The regulatory framework for this action is established by the NMPA, which oversees medical product safety and efficacy. Siemens Medical Diagnostics is taking required actions to address this concern, with detailed information on affected models, specifications, and batches provided in an attached "Medical Device Recall List" and "Medical Device Recall Event Report Form".