Z-1421-2017Class II

IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170

Name: Z-1421-2017 IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170
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 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the... 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-1421-2017
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 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 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: 11963
Distribution: US Nationwide distribution including Puerto Rico
Product codes and lots: SMN: 10381181: L2KPW2 kit lot 453 L2KPW2 kit lot 454 L2KPW2 kit lot 455 L2KPW2 kit lot 456 L2KPW2 kit lot 457 L2KPW2 kit lot 458 L2KPW2 kit lot 459 L2KPW2 kit lot 460 L2KPW2 kit lot 462 L2KPW2 kit lot 463 L2KPW2 kit lot 464 L2KPW2 kit lot 465 L2KPW2 kit lot 467 L2KPW2 kit lot 468 L2KPW2 kit lot 470 L2KPW2 kit lot 471 L2KPW2 kit lot 472 L2KPW2 kit lot 474; SMN: 10381170: L2KPW6 kit lot 453 L2KPW6 kit lot 454 L2KPW6 kit lot 455 L2KPW6 kit lot 456 L2KPW6 kit lot 457 L2KPW6 kit lot 458 L2KPW6 kit lot 459 L2KPW6 kit lot 460 L2KPW6 kit lot 461 L2KPW6 kit lot 463 L2KPW6 kit lot 464 L2KPW6 kit lot 465 L2KPW6 kit lot 466 L2KPW6 kit lot 467 L2KPW6 kit lot 469 L2KPW6 kit lot 470 L2KPW6 kit lot 471 L2KPW6 kit lot 472 L2KPW6 kit lot 474

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1421-2017
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)