“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
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
Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
Description du dispositif
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.
ADVIA Centaur BR Assay for CA 27.29, ADVIA Centaur BR Assay for CA 15-3. An in vitro diagnostic devices (IVD)ADVIA Centaur BR Assay for CA 27.29Reference numbers: 03896216 and 02419937ADVIA Centaur BR Assay for CA 15-3Reference numbers: 01157807 and 03204829Multiple lot numbers