IMMULITE 2000 PSA Assay (Siemens) – High-Dose Hook Effect Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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 uscctsfcaecfax.team@siemens-healthineers.com. Or to fax this completed form to the Customer Care Center at (312) 275-7795.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026