Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0464-2025 — IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

U.S. FDA — Device Enforcement · United States · 2024-09-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0464-2025
Date of alert
2024-09-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10706281
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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