Z-1419-2017Class II

Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743

Name: Z-1419-2017 Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743
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 Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in 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-1419-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-04
Posted: 2017-03-09
Terminated: 2019-07-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
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: 1148
Distribution: US Nationwide distribution including Puerto Rico
Product codes and lots: 16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1419-2017
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)