The Recall Desk

FDA (Devices) recall action 72597

Ortho-Clinical Diagnostics recalled 4 products on 2016-01-20

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-01-20
Critical
0
Units
—

Why these products were recalled

Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.

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

1–4 of 4

  • HighFDA (Devices)··2016-01-20

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage:
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    Distribution
    0 states
  • HighFDA (Devices)··2016-01-20

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of
    Category
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    0 states
  • HighFDA (Devices)··2016-01-20

    Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-01-20

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Distribution
    0 states