Z-0162-2013Class II

Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF...

Name: Z-0162-2013 Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-09-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-09-11 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS... on 2012-09-11. FDA classified it as Class II and gives the reason as "BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0162-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-11
Posted: 2012-10-28
Terminated: 2016-09-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: MOI System, Test, Immunological, Antigen, Tumor
Reason for recall: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0162-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-27

Product code MOI

K982680Class IIChiron Diagnostics Corporation Acs: Centaur Br ImmunoassayChiron Diagnostics Corp. / cleared 1998-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)