Z-2313-2012Class II

Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra...

Name: Z-2313-2012 Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-07-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-07-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA... on 2012-07-25. FDA classified it as Class II and gives the reason as "Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays". 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-2313-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Posted: 2012-09-06
Terminated: 2015-11-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Product code: NBC Test, Natriuretic Peptide
Reason for recall: Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an "URGENT DEVICE RECALL NOTICE" dated July 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Response Form was included for customers to complete and return via fax to (302) 631-7597. Contact your local Sales Representative for questions regarding this notice.
Quantity in commerce: 2 Packs = 15879 and 6 Packs = 7414
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.
Product codes and lots: Lot # Expiry Date 2 Pack 76129 22 JUN 2012 77542 22 JUN 2012 78696 22 JUN 2012 80828 26 SEP 2012 80857 26 SEP 2012 81441 26 SEP 2012 82189 26 SEP 2012 83647 26 SEP 2012 84772 26 SEP 2012 86037 13 JAN 2013 86783 13 JAN 2013 88712 13 JAN 2013 90056 13 JAN 2013 91002 13 JAN 2013 93126 13 JAN 2013 6 Pack 76102 22 JUN 2012 76432 22 JUN 2012 77075 22 JUN 2012 78264 22 JUN 2012 79037 22 JUN 2012 81006 26 SEP 2012 82539 26 SEP 2012 83321 26 SEP 2012 84123 26 SEP 2012 85795 13 JAN 2013 86698 13 JAN 2013 88318 13 JAN 2013 89286 13 JAN 2013 90490 13 JAN 2013 91672 13 JAN 2013 93129 13 JAN 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2313-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2313-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code NBC

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)