Z-1515-2013Class II

ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating...

Name: Z-1515-2013 ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2013-05-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-05-14 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays on 2013-05-14. FDA classified it as Class II and gives the reason as "iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability". 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-1515-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-14
Posted: 2013-06-06
Terminated: 2015-03-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Product code: JIT Calibrator, Secondary
Reason for recall: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Root cause tag: manufacturing process
FDA root cause: No Marketing Application
Action: Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.
Quantity in commerce: 198 (6 pk)
Distribution: Nationwide Distribution.
Product codes and lots: Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1515-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1512-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1513-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1514-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1515-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code JIT

K020217Class IAcs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. / cleared 2002-03-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)