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Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System, Catalog No. 6844461
Recalled March 13, 2024 · FDA recall Z-1228-2024 · Ortho-Clinical Diagnostics
Hazard
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported. · FDA Class II
Units
44 US; 35 OUS
Sold at
Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
Description
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Product
VITROS XT 7600 Integrated System, Catalog No. 6844461
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →