Z-1418-2017Class II

ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111

Name: Z-1418-2017 ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2017-01-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-01-04 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative... on 2017-01-04. FDA classified it as Class II and gives the reason as "DHEA-S causes falsely elevated progesterone results". 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-1418-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-04
Posted: 2017-03-09
Terminated: 2019-07-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension VistaSystem. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Product code: JLS Radioimmunoassay, Progesterone
Reason for recall: DHEA-S causes falsely elevated progesterone results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent Medical Device Correction (UMDC) letter dated January 4, 2017 to all affected Siemens Healthcare Diagnostics customers in the United States dated . An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 4, 2017. These letters identified the affected product problem and actions to be taken. For questions contact your local Siemens Customer Care Center or your local Siemens Technical support.
Quantity in commerce: 76,107
Distribution: US Nationwide distribution including Puerto Rico
Product codes and lots: SMN: 10310305: 75422274 83380274 89389274 99473274 8713275 19796275 30565275 38674275 46515276 55704276 66971276 78934276 80930277; SMN: 10315522: 74355274 80476274 87497274 20274 7772275 14822275 25943275 35303275 43229276 46525276 55505276 67430276 80448276 81415277; SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1418-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1418-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1419-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1420-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1421-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09

Product code JLS

K932955Class ICiba Corning Acs Progesterone ImmunoassayCiba Corning Diagnostics Corp. / cleared 1993-08-02

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)