The Recall Desk

FDA (Devices) recall action 75523

Siemens Healthcare Diagnostics, Inc recalled 2 products on 2016-11-23

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
2016-11-23
Critical
0
Units
48,955

Why these products were recalled

CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.

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.

1–2 of 2

  • ModerateFDA (Devices)··2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
    Category
    Distribution
    0 states