Z-0173-2014Class III

ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in...

Name: Z-0173-2014 ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2013-08-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-08-16 / Terminated / root cause: packaging

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur... on 2013-08-16. FDA classified it as Class III and gives the reason as "PTH Calibrator packaged with only high calibrator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0173-2014
Classification: Class III
Status: Terminated
Initiated: 2013-08-16
Posted: 2013-11-06
Terminated: 2014-02-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: PTH Calibrator packaged with only high calibrator.
Root cause tag: packaging
FDA root cause: Packaging
Action: Packaging error was brought to Siemens' attention through escalations received from (3) customers in the United States. Internal Investigation confirmed the issue was limited to the five (5) kits distributed to these customers. As the customers were aware of the issue and non affected product was provided to the customers to use during Siemens' investigation, no further communication was warranted.
Quantity in commerce: 595 kits total (5 kits with packaging error)
Distribution: Nationwide Distribution including MD, PA, and CT.
Product codes and lots: Kit Lot: 14136A16 04 Mar 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0173-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0173-2014	Class III	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-06

Product code CEW

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)