Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Anti-HBe Reagent Pack Recalled by ORTHO-CLINICAL DIAGNOSTICS Due to The firm is extending their previous July 2018...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ORTHO-CLINICAL DIAGNOSTICS directly.
Affected Products
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.
Quantity: 3429 units (100 tests per unit)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ORTHO-CLINICAL DIAGNOSTICS
ORTHO-CLINICAL DIAGNOSTICS has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report