VITROS Anti-HBe Reagent Pack recalled over hepatitis A risk

Recall date

November 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to he…

Recall number

Z-0687-2019

FDA classification

Class II

Brand / firm

ORTHO-CLINICAL DIAGNOSTICS

Sold / distributed

Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and Un…

Why it was recalled

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.