The Recall Desk

FDA (Devices) recall action 65207

Ortho-Clinical Diagnostics recalled 5 products on 2013-07-10

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2013-07-10
Critical
0
Units
31

Why these products were recalled

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

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.

States named across these recalls

1–5 of 5

  • SevereFDA (Devices)··2013-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems Due to Electrical Short

    Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.

    Product
    1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest
    Category
    Distribution
    39 states
  • SevereFDA (Devices)··2013-07-10

    Ortho Assay Software Server Recalled Due to Electrical Short and Heat

    Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software Server because an electrical short caused heat accumulation and melted wiring.

    Product
    ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific
    Category
    Distribution
    39 states
  • SevereFDA (Devices)··2013-07-10

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an electrical short that caused heat accumulation and melted wiring.

    Product
    VITROS 5600 Integrated System (product code 6802413) Product Usage: 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
    Category
    Distribution
    39 states
  • SevereFDA (Devices)··2013-07-10

    Ortho-Clinical VITROS 4600 Chemistry System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because an electrical short in the connector caused heat accumulation and melted wiring.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, io
    Category
    Distribution
    39 states
  • SevereFDA (Devices)··2013-07-10

    Ortho-Clinical VITROS 3600 Immunodiagnostic System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic Systems because an electrical short caused heat accumulation that melted wiring and connectors.

    Product
    VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: 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
    39 states