Recall Z-0162-2013 ยท MOI System, Test, Immunological, Antigen, Tumor
Siemens Healthcare Diagnostics, Inc
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
| Date | Oct 28, 2012 (initiated Sep 11, 2012) |
| Status | Terminated |
| Reason | BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return. |
| Quantity | 15,455 kits |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY Chiron Diagnostics Corp., Oct 15, 1998 |