China NMPA Product Recall - Fully automated biochemical analyzer

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., representing manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall for its Fully Automated Biochemical Analyzer. This action was reported to the National Medical Products Administration (NMPA) on April 10, 2015. The core issue involves a defect in the product's internal reagent management software, specifically in VITROS 5.1 analyzers running software version 2.8 or below. This software flaw can lead to incorrect identification of test kits. The problem occurs if an operator activates Dry Tablet Supply 1 prematurely and then loads a cartridge into Dry Tablet Supply 2, potentially causing the software to misidentify the cartridge and record an erroneous product name, which could compromise test accuracy. The affected model/specification is 6801375, with 170 units sold in China. Under NMPA's regulatory oversight, the required corrective action involves distributing and loading a new software version onto all affected VIT analyzers to resolve the misidentification issue. Johnson & Johnson Medical (China) Ltd. has notified affected distributors and hospitals to facilitate this essential software update and maintain the reliability of clinical testing.