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

Recall Z-1821-2025 — Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

U.S. FDA — Device Enforcement · United States · 2025-04-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1821-2025
Date of alert
2025-04-15
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)
10995498
Reported risk: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.