The Recall Desk

FDA (Devices) recall action 82311

Ortho-Clinical Diagnostics recalled 7 products on 2019-05-15

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2019-05-15
Critical
0
Units
486

Why these products were recalled

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

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.

1–7 of 7

  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical VITROS ECi Immunodiagnostic System Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical VITROS ECi/ECiQ Immunodiagnostic System Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 45 VITROS ECi/ECiQ Immunodiagnostic Systems worldwide due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical VITROS 3600 Immunoassay System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Distribution
    0 states