The Recall Desk

FDA (Devices) recall action 74568

Beckman Coulter Inc. recalled 3 products on 2016-08-10

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
2016-08-10
Critical
0
Units
—

Why these products were recalled

Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2016-08-10

    Beckman Coulter Recalls AU480 Chemistry Analyzers Due to Leaking C Cups

    Beckman Coulter is recalling AU480 Chemistry Analyzers because leaking C cups can cause coolant to short-circuit the instrument's circuit boards.

    Product
    AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other access
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2016-08-10

    Beckman Coulter AU5800 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU5800 Chemistry Analyzers because cracked C cups can leak coolant onto circuit boards, causing short-circuits and instrument stop mode.

    Product
    AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other acces
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2016-08-10

    Beckman Coulter AU680 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU680 Chemistry Analyzers because leaking and cracked C cups can cause coolant to leak onto circuit boards, resulting in short-circuits and instrument stop mode.

    Product
    AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other access
    Category
    Distribution
    2 states