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

Ausendo Medical Devices Trading (China) Co., Ltd., acting as the agent for manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall for its Phenytoin Assay Dry Tablets (Immunometry). This action, reported on July 3, 2017, and published by the National Medical Products Administration (NMPA) on July 27, 2017, was prompted by the discovery of a negative bias when the product was used to test citrate plasma samples. The issue, affecting product model 8298671 and all batch numbers, is primarily attributed to the dilution effect of liquid anticoagulant in citrate plasma tubes on the sample. No bias was observed with serum or heparinized plasma samples from the same patients. The recall impacts products globally, with 11 boxes sold in China. To address this, customers were immediately instructed to cease using citrate plasma samples with the Phenytoin Assay Dry Tablets. Heparinized plasma or serum samples remain suitable for testing. Ortho-Clinical Diagnostics will revise the product's instructions for use to remove citrate plasma as a recommended sample type, thereby ensuring accurate diagnostic results and patient safety under the NMPA’s regulatory oversight.