# FDA recall Z-0464-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-09-30.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-0464-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-30
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2025

## Citation

> AI Analytics. FDA recall Z-0464-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0464-2025. Source: US FDA. Licensed CC0.

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