The Recall Desk

FDA (Devices) recall action 87356

Ortho-Clinical Diagnostics, Inc. recalled 2 products on 2021-03-24

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-03-24
Critical
0
Units
14,959

Why these products were recalled

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.

    Product
    VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Recalled for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagents because they may produce false reactive results when used with Remel M4RT Viral Transport Media.

    Product
    VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassa
    Category
    Distribution
    0 states