FDA-Device2013-05-01Class III
VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Sold states
Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Affected count
1464 units
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1161-2013Don't want to check this manually?
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