The Recall Desk

FDA (Devices) recall action 66958

Beckman Coulter Inc. recalled 2 products on 2014-02-26

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
2014-02-26
Critical
0
Units
4

Why these products were recalled

The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

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

  • ModerateFDA (Devices)··2014-02-26

    Beckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer

    Beckman Coulter is recalling the UniCel DxI 600 Access Immunoassay System Analyzer because non-conforming bushings may cause incorrect test results.

    Product
    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-02-26

    Beckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings

    Beckman Coulter is recalling three Access 2 Immunoassay System Analyzers because non-conforming bushings may generate incorrect results.

    Product
    Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Distribution
    1 state