Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The A

Recalled April 12, 2017 · FDA recall Z-1749-2017 · Siemens Healthcare Diagnostics

Hazard

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

Units

1259 kits

Sold at

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

Description

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

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 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.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →