Ortho-Clinical Diagnostics, Inc. has recalled 86 VITROS diagnostic systems, including the VITROS 3600, 4600, 5600, XT 3400, and XT 7600 models running Software Version 3.8.1. A software defect prevents quality control (QC) baseline statistics from updating correctly when changed by a user, which can lead to the reporting of incorrect patient test results. These systems are used in clinical laboratories and hospitals for immunodiagnostics and chemistry testing. Because of the risk of erroneous medical data, laboratories must take immediate action to verify their software versions and follow manufacturer instructions.
The software failure prevents the system from properly applying user-defined quality control updates, which means the machine may provide inaccurate laboratory results without the operator realizing the data is compromised. Incorrect results could lead to improper medical diagnoses or delayed treatments for patients.
Software update and quality control verification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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