The Recall Desk

FDA (Devices) recall action 69830

Ortho-Clinical Diagnostics recalled 3 products on 2015-01-21

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
2015-01-21
Critical
0
Units
—

Why these products were recalled

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2015-01-21

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. 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
    1 state
  • ModerateFDA (Devices)··2015-01-21

    Ortho VITROS 5600 System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemist
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2015-01-21

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using bot
    Category
    Distribution
    1 state