The Recall Desk

FDA (Devices) recall action 67058

Beckman Coulter Inc. recalled 4 products on 2014-07-02

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
2014-07-02
Critical
0
Units
—

Why these products were recalled

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

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

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2014-07-02

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-07-02

    Beckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 600 and DxH 800 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.

    Product
    Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Distribution
    1 state