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

The National Medical Products Administration (NMPA) reported a voluntary Class II recall initiated by Ausendo Medical Devices Trading (China) Co., Ltd. on behalf of Ortho-Clinical Diagnostics, Inc. The recall, reported on July 3, 2017, and published on July 27, 2017, pertains to their Phenytoin Assay Dry Tablets (Immunometry), Registration No.: 20152402811, specifically model 8298671. The core issue identified is a potential for negative bias when the assay tablets are utilized with citrate plasma samples. This inaccuracy is primarily attributed to the dilution effect caused by the liquid anticoagulant within citrate plasma tubes. Significantly, no such bias was observed when testing serum or heparinized plasma samples from the same patients. As required actions, customers have been instructed to immediately discontinue using citrate plasma samples with the phenytoin assay dry tablets. The manufacturer confirmed that heparinized plasma or serum samples remain appropriate for testing. Ortho-Clinical Diagnostics also committed to revising the product's Instructions for Use to officially remove citrate plasma from the list of recommended sample types, ensuring compliance with NMPA's regulatory standards and promoting accurate diagnostic results.