Z-0464-2025Class II

IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

Name: Z-0464-2025 IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-09-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-09-30 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) on 2024-09-30. FDA classified it as Class II and gives the reason as "The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0464-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-30
Posted: 2024-11-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Product code: MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Reason for recall: The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction letter dated 9/30/24 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, that may have been affected. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution IMMULITE 2000 and IMMULITE 2000 XPi kit lots D168 and above meet the IFU high-dose hook effect claim. Siemens continues to investigate root cause of the issue observed with the impacted kit lots. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please send a scanned copy of the completed form via email to [email protected]. Or to fax this completed form to the Customer Care Center at (312) 275-7795.
Quantity in commerce: 7,332 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: SMN 10706281: UDI - 00630414982212, Lot Number D164; SMN 10706282: UDI - 00630414982229, Lot Number D166; SMN 10380896 (OUS): UDI - 00630414961958; SMN 10380996 (OUS): UDI - 00630414961965; OUS Lot Numbers: 438, 439, 440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14

Product code MTF

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)