Device product
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 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.
Z-0162-2013
Product summary
- Event
- Event 63167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,455 kits
- Official record key
device-enforcement:Z-0162-2013
Official wording
Reason: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
Code information: BR Assay for CA 27.29 BR Assay Kit Lots ReadyPack¿ Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198 ReadyPack¿ Lot Number Ending in 202: 93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202. BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199: 87425199,85862199,86949199,85945199
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
Derived failure modes
-
Unknown
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.