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

Ortho-Clinical Diagnostics, Inc., in cooperation with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of its Phenytoin Assay Dry Tablets (Immunorate Method) with coat number 0115. The recall, overseen by China's National Medical Products Administration (NMPA), was triggered by a reported bias in the product's testing accuracy, as documented under its CFDA (Imported) registration. Johnson & Johnson (Shanghai) implemented comprehensive corrective actions. Starting November 16, 2010, they notified customers via email and telephone about the issue, halting further shipments of the affected batch and retrieving all identified products. The company reported a 100% effectiveness check for the recall, with all affected units corrected. The recall plan was fully executed and completed by November 23, 2010. No domestic customer complaints were received regarding this specific issue by the report date of November 29, 2010, underscoring a prompt and contained resolution to the product accuracy concern.