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

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