FDA-Device2024-01-31Class II
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Ortho-Clinical Diagnostics, Inc.
Hazard
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Sold states
Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
Affected count
6,920 US; 57 OUS
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0772-2024Don't want to check this manually?
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