The Recall Desk

FDA (Devices) recall action 69084

Siemens Healthcare Diagnostics recalled 2 products on 2014-10-08

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
2014-10-08
Critical
0
Units
—

Why these products were recalled

The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full

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

1–2 of 2

  • ModerateFDA (Devices)··2014-10-08

    Siemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.

    Product
    ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical di
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-10-08

    Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.

    Product
    ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagn
    Category
    Distribution
    0 states