The Recall Desk

FDA (Devices) recall action 69437

Beckman Coulter Inc. recalled 2 products on 2014-11-12

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
2014-11-12
Critical
0
Units
—

Why these products were recalled

Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.

Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.

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

1–2 of 2

  • ModerateFDA (Devices)··2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte conce
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-11-12

    Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

    Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes con
    Category
    Distribution
    0 states