Z-2289-2019Class II

IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

Name: Z-2289-2019 IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-07-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-07-10 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 on 2019-07-10. FDA classified it as Class II and gives the reason as "There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2289-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-10
Posted: 2019-08-17
Terminated: 2024-05-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Product code: JLS Radioimmunoassay, Progesterone
Reason for recall: There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction notification letters were sent to customers beginning 7/10/19. Actions to be Taken by the Customer 1) Please review this letter with your Medical Director. 2) If interference is suspected, follow your established internal procedures to investigate the interference. 3) Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4) If you have received any complaints of illness or adverse events associated with the products, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. The firm reports that a removal at this time is not necessary because: "Siemens does not intend to remove the product as based on available data, it is estimated the occurrence is <1%. Siemens recommends that the laboratories follow their internal procedures if interference is suspected. A Follow up Urgent Medical Device Correction dated 1/13/20 was sent to customers. Actions to be Taken by the Customer Note: Interference will not be detected by quality control and the presence of the interference may not be readily identifiable. Follow your established internal procedures to determine if additional testing is needed to identify samples with suspected interference and to determine if the patient sample result is accurate. A potential approach to identify interference is to dilute the sample. In-house studies have shown that a 1:5 dilution of the sample is effective in diluting out the potential interferant. Please note that for samples with an undiluted result of d 1 ng/mL, greater variability could potentially be observed after dilution due to assay precision in this region. Instructions Please review this letter with your Medical Director. Complete and return
Quantity in commerce: 4780 (6266 additional as of 1/13/20)
Distribution: Global distribution. US Nationwide.
Product codes and lots: kit lots 0259 and above; UDI: 00630414985732

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2289-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2289-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-17
Z-2290-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-17

Product code JLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)