Z-1512-2013Class II

ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative...

Name: Z-1512-2013 ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative...
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 ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) 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-1512-2013
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 ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Product code: CEW Radioimmunoassay, Parathyroid Hormone
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: 309 (100 test) kits
Distribution: Nationwide Distribution.
Product codes and lots: Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2013
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 CEW

K121981Class IIAdvia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics / cleared 2013-03-21

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)