China NMPA Product Recall - VITROS 5.1 FS Fully Automated Biochemical Analyzer, VITROS 4600 Fully Automated Biochemical Analyzer, VITROS 5600 Fully Automated Biochemical and Immunoassay Analyzer

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall on May 14, 2015, for several models of its VITROS Fully Automated Biochemical Analyzers, specifically VITROS 5.1 FS, VITROS 4600, and VITROS 5600. The manufacturer, Ortho-Clinical Diagnostics, Inc., identified that these analyzers could issue potentially biased test results for urine samples. The core issue arises when a testing order includes urine tests requiring different or no pretreatment, or involves multiple pretreatment groups, leading to the system processing unacceptable samples. While the improper pretreatment could positively or negatively affect results, the magnitude of bias for most analytes is generally not considered clinically significant. This recall is overseen by the National Medical Products Administration (NMPA) in China. As required actions, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is mandated to inform all affected distributors and customers about this recall. Additionally, they must provide further notification once Ortho-Clinical Diagnostics formulates an approved corrective solution to address the identified product deficiency.