Z-1748-2017Class II

Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The...

Name: Z-1748-2017 Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2017-03-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-03-08 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic... on 2017-03-08. FDA classified it as Class II and gives the reason as "Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1748-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-08
Posted: 2017-04-06
Terminated: 2020-01-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 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, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III 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: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to customers in the United States on March 08, 2017 to be delivered to customers on March 09, 2017and (UFSN) was sent for distribution to customers outside the United States on March 08, 2017. These notices inform customers of the potential and mitigation action to be taken for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. This issue affects all current and future lots of ADVIA Centaur Systems BR reagents until a solution is implemented. Fax-back forms included with letter used to confirm that the customers received the Urgent Medical Device Correction to the Customer Care Center at 312-275-7795. For questions regarding this recall call 508-668-5000. .
Quantity in commerce: 1900 kits
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1748-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1747-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1748-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06
Z-1749-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)