FDA-Device2014-01-01Class II
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
Sold states
Nationwide distribution - all states.
Affected count
1,920 kits
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0557-2014Don't want to check this manually?
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