Class II

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

Siemens Healthcare Diagnostics, Inc. · September 30, 2024

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).

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

7,332 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0464-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Siemens Healthcare Diagnostics, Inc. Medical Device Recall: IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) | SafeCheck