Siemens recalls Atellica IM Homocysteine Calibrator (2 Pack) due to unstable calibrators causing inaccurate test results. Affected lots may give false high readings. Contact Siemens for details.
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.
Siemens is recalling Atellica IM Homocysteine Calibrator (2 Pack) because certain lots are unstable and produce inaccurate test results. This could lead to false high readings in homocysteine tests, potentially affecting medical decisions.
The calibrator may become unstable over time, causing test results to be higher than they should be. This increased positive bias could lead to false high homocysteine readings, which might affect medical decisions if not corrected.
Lab users who purchased the Atellica IM Homocysteine Calibrator (2 Pack) with Siemens Material Number 10995498 are affected. Those using the calibrator for homocysteine testing in medical labs are most at risk.
Check for Siemens Material Number 10995498 on the calibrator packaging. Look for lot numbers 86236A74, 44206A75, 25675A77, 44505A78, or 52364A79. The recall was updated on May 8, 2026.
Look for lot numbers 86236A74, 44206A75, 25675A77, 44505A78, or 52364A79 on the packaging.
Certain lots of Atellica IM Homocysteine Calibrator are unstable and cause inaccurate test results, leading to increased positive bias in homocysteine readings.
Check the lot number on the packaging. If it matches the affected lots listed, contact Siemens Healthcare for instructions.
The recall is for inaccurate test results, not immediate safety risks. However, false high readings could affect medical decisions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1821-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1821-2025 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
