IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
FDA Recall Z-0464-2025 · Posted 2024-11-14
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeMTF
Date Initiated2024-09-30
Product Quantity7,332 units
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).
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.