The Recall Desk

FDA (Devices) recall action 81682

ORTHO-CLINICAL DIAGNOSTICS recalled 3 products on 2019-01-09

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-01-09
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • ModerateFDA (Devices)··2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HBe Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.

    Product
    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 h
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    0 states
  • HighFDA (Devices)··2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.

    Product
    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems,
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  • HighFDA (Devices)··2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV
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    0 states