Z-0128-2015Class II

ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system...

Name: Z-0128-2015 ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-10-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-10-09 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number... on 2012-10-09. FDA classified it as Class II and gives the reason as "Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system". 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-0128-2015
Classification: Class II
Status: Terminated
Initiated: 2012-10-09
Posted: 2014-10-24
Terminated: 2015-06-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Product code: DBF Ferritin, Antigen, Antiserum, Control
Reason for recall: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued an Urgent Field Safety Notice via e-mail to all US customers affected on October 9, 2012. This notice informs the customer of the Field Correction and the actions that need to be taken. The Urgent Field Safety Notice instructs customers that upon receipt of Calibrator C Lots ending in 25 and higher (Cal C lots CC25LA and higher and Cal C lots CC25HA and higher), discontinue use of the Calibrator C lots ending in 22 and 23 with the ADVIA Centaur Ferritin assay when used on the ADVIA Centaur CP system. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Further questions please call (508) 668-5000
Quantity in commerce: 8263 kits
Distribution: Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.
Product codes and lots: Lot numbers: 82052A22 Exp Date 01/19/2013 82335A22 82909A22 85268A22 86701B22 88921B22 89956B22 90925B22 91336B22 95231A23 Exp. Date: 01/16/2013 95553A23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0128-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24
Z-0129-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24
Z-0130-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

Product code DBF

K110736Class IIAdvia Chemistry Ferritin (Frt) MethodSiemens Healthcare Diagnostics, Inc. / cleared 2011-08-17

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)