FDA-Device2020-05-06Class III
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Ortho Clinical Diagnostics
Hazard
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Sold states
US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.
Affected count
3181
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2020Don't want to check this manually?
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