The Recall Desk

FDA (Devices) recall action 68790

Ortho-Clinical Diagnostics recalled 3 products on 2014-08-13

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
2014-08-13
Critical
0
Units
—

Why these products were recalled

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2014-08-13

    Ortho VITROS 3600 Immunodiagnostic System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 3600 Immunodiagnostic System --- 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. The VITROS Software is a part of the VITROS 3600, 4600, & 5
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-08-13

    Ortho VITROS 4600 Chemistry System Recalled for Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, r
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-08-13

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 5600 Integrated System --- 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 Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Pr
    Category
    Distribution
    1 state