The Recall Desk

FDA (Devices) recall action 66253

Beckman Coulter Inc. recalled 2 products on 2013-11-13

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
2013-11-13
Critical
0
Units
—

Why these products were recalled

The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.

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

1–2 of 2

  • ModerateFDA (Devices)··2013-11-13

    Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-13

    Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Distribution
    0 states