FDA-Device2018-12-26Class II
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Ortho-Clinical Diagnostics
Hazard
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Sold states
US Nationwide Distribution
Affected count
682
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0652-2019Don't want to check this manually?
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