Z-1420-2017Class II

IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128

Name: Z-1420-2017 IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128
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 IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000... 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-1420-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-04
Posted: 2017-03-09
Terminated: 2019-07-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid 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: 9076
Distribution: US Nationwide distribution including Puerto Rico
Product codes and lots: LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1420-2017
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)