The Recall Desk

FDA (Devices) recall action 63505

Beckman Coulter Inc. recalled 3 products on 2012-11-28

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
2012-11-28
Critical
0
Units
2,188

Why these products were recalled

The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.

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.

1–3 of 3

  • HighFDA (Devices)··2012-11-28

    Beckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems

    Beckman Coulter is recalling 432 UniCel Dxl 600 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.

    Product
    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human bod
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-11-28

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications

    Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense probe assemblies.

    Product
    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-28

    Beckman Coulter Recalls UniCel Dxl 800 Access Immunoassay Systems

    Beckman Coulter is recalling 1,756 UniCel Dxl 800 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.

    Product
    UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human bod
    Category
    Distribution
    0 states