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Terminated

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.

FDA Recall Z-0162-2013 · Posted 2012-10-28

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeMOI
Date Initiated2012-09-11
Date Terminated2016-09-01
Product Quantity15,455 kits

Reason for Recall

BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYChiron Diagnostics Corp. · 1998-10-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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