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Ortho-Clinical Diagnostics recalls VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Recalled January 1, 2014 · FDA recall Z-0557-2014 · 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. · FDA Class II
Units
1,920 kits
Sold at
Nationwide distribution - all states.
Description
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.
Product
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →