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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Increased Rate of Initial and/or Repeat Reactive Results for the Auszyme Monoclonal Test for Hepatitis B Surface Antigen (HBsAg)

Audience: Users of all variants of BD Vacutainer SST glass and Plus plastic, SST II tubes, and BD Microtainer collection tubes on Abbott Diagnostics' Auszyme Monoclonal Assay (list No 1980).

Abbott Diagnostics and Becton Dickinson have initiated a joint investigation into the impact of BD Vacutainer SST and BD Microtainer tubes on Abbott immunoassays. The use of BD Vacutainer SST and BD Microtainer collection tubes with Auszyme may result in an increase in initial and/or repeatable reactive results that do not confirm with the Abbott HBsAg Confirmatory assay. Please note that this issue does not impact the Abbott HBsAg Confirmatory assay. Additional information can be obtained at www.bd.com/vacutainer/techbulletins.