The Recall Desk

FDA (Devices) recall action 76766

Siemens Healthcare Diagnostics, Inc recalled 3 products on 2017-04-12

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-04-12
Critical
0
Units
5,609

Why these products were recalled

Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

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.

1–3 of 3

  • ModerateFDA (Devices)··2017-04-12

    Siemens ADVIA Centaur BR Assay Recalled for Potential Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.

    Product
    Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, AD
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-04-12

    Siemens ADVIA Centaur BR Assay Recalled for Potential Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.

    Product
    Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADV
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-04-12

    Siemens ADVIA Centaur BR Assay Recalled for Potential Syphilis Assay Interference

    Siemens is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay, which may affect test accuracy.

    Product
    Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centau
    Category
    Distribution
    0 states