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Recall Observatory FDA recall evidence

Device 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¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Z-1748-2017

March 08, 2017

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 76766
Status
Terminated
Classification
Class II
Quantity
1900 kits
Official record key
device-enforcement:Z-1748-2017

Official wording

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

Code information: All lot codes

Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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