The Recall Desk

FDA (Devices) recall action 76688

Beckman Coulter Inc. recalled 3 products on 2017-04-12

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
2017-04-12
Critical
0
Units
—

Why these products were recalled

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2017-04-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests.

    Product
    Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-04-12

    Beckman Coulter Recalls UniCel DxC 600i SYNCHRON Access Clinical Systems

    Beckman Coulter is recalling specific UniCel DxC 600i SYNCHRON Access Clinical Systems because a circuit board defect can cause the device to stop running and cancel tests.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentr
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-04-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests in process.

    Product
    Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body
    Category
    Distribution
    1 state