The Recall Desk

FDA (Devices) recall action 69074

Siemens Healthcare Diagnostics recalled 2 products on 2014-09-24

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
2014-09-24
Critical
0
Units
—

Why these products were recalled

The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

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

1–2 of 2

  • ModerateFDA (Devices)··2014-09-24

    Siemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading

    Siemens is correcting ADVIA Centaur systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015,
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-09-24

    Siemens ADVIA Centaur Immunoassay Systems Recalled for Sample Rack Loading Issues

    Siemens Healthcare Diagnostics is correcting ADVIA Centaur and XP systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnosti
    Category
    Distribution
    0 states