The Recall Desk

FDA (Devices) recall action 62706

Beckman Coulter Inc. recalled 3 products on 2012-08-29

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
2012-08-29
Critical
0
Units
—

Why these products were recalled

The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.

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

1–3 of 3

  • HighFDA (Devices)··2012-08-29

    Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-29

    Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations fo
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    0 states
  • HighFDA (Devices)··2012-08-29

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualita
    Category
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    0 states