The Recall Desk

FDA (Devices) recall action 71835

Beckman Coulter Inc. recalled 2 products on 2015-09-09

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
2015-09-09
Critical
0
Units
710

Why these products were recalled

Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.

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

1–2 of 2

  • HighFDA (Devices)··2015-09-09

    Beckman Coulter Recalls Isoton 4 Diluent for Hematology Systems

    Beckman Coulter is recalling specific lots of Isoton 4 Diluent because they may compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.

    Product
    COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2015-09-09

    Beckman Coulter Recalls LH Series Diluent Due to Cuvette Compromise Risk

    Beckman Coulter is recalling LH Series Diluent because it may eventually compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.

    Product
    COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
    Category
    Distribution
    2 states