Z-1122-2013Class II

ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative...

Name: Z-1122-2013 ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2013-03-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-03-13 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D on 2013-03-13. FDA classified it as Class II and gives the reason as "Negative bias in patient samples for Vitamin D". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1122-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-13
Posted: 2013-04-15
Terminated: 2015-03-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
Product code: JIS Calibrator, Primary
Reason for recall: Negative bias in patient samples for Vitamin D
FDA root cause: No Marketing Application
Action: Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
Quantity in commerce: 107 6pk Cals
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1119-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15
Z-1120-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15
Z-1121-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15
Z-1122-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15

Product code JIS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)