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Ortho-Clinical Diagnostics Recall: VITROS¿ Immunodiagnostic Products Anti-HBs (total antib

Ortho-Clinical Diagnostics Recall: VITROS¿ Immunodiagnostic Products Anti-HBs (total antib is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ortho-Clinical Diagnostics; Product: VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent

Recalling firmOrtho-Clinical Diagnostics
ProductVITROS¿ 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.
Reason for recallOrtho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionWorldwide 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.
Recall initiated20121101
Recall numberZ-1161-2013
Categorydevice
StateNY
CountryUnited States

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