Reported Nov 7, 2012 · Terminated
Siemens ADVIA Centaur BR Assay
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
Siemens ADVIA Centaur BR Assay
5 of 5 products
| Model / number | Product as published |
|---|---|
02419937 | Catalog Number: US: (10214722) (50 Tests) |
03896216 | (10334837)(250 Tests) Not CE Marked |
03204829 | OUS: (10310271)(50 Tests) |
01157807 | (1 0314722) (250 Tests) CE Marked |
09010686 | (10340081)(250 Tests). 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 and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill 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. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198 ReadyPack¿ 2 Lot Number Ending in 202: 93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202. BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots 3 Lot Number Ending in 199: 87425199,85862199,86949199,85945199 - Amount recalled
- 15,455 kits
Where it was sold
- Nationwide
Why it was recalled
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
This product could cause temporary or reversible health problems — stop using it.
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