The Recall Desk

FDA (Devices) recall action 66826

Beckman Coulter Inc. recalled 2 products on 2013-12-18

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-12-18
Critical
0
Units
—

Why these products were recalled

Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.

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

1–2 of 2

  • HighFDA (Devices)··2013-12-18

    Beckman Coulter Recalls LH 750 Hematology Analyzers Due to Optical Degradation

    Beckman Coulter is recalling LH 750 Hematology Analyzers because optical degradation may delay reporting results for specific blood cell counts.

    Product
    Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-18

    Beckman Coulter Recalls LH 750 and LH 780 Hematology Systems

    Beckman Coulter is recalling LH 750 and LH 780 Hematology Systems because optical degradation may delay reporting results for specific blood cell counts.

    Product
    Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 780…
    Category
    Distribution
    0 states