FDA-Device2024-03-13Class II
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Ortho-Clinical Diagnostics, Inc.
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.
Sold states
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.
Affected count
1 US; 36 OUS
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2024Don't want to check this manually?
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