Siemens Healthcare recalls ADVIA Centaur HCY Calibrator (2 Pack) with material number 10310376 due to calibration instability causing inaccurate test results. Affected lots include 86237A74, 44207A75, and additional lots listed in the recall notice.
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 Healthcare is recalling ADVIA Centaur HCY Calibrator (2 Pack) kits because certain lots have calibration instability that can lead to inaccurate test results. This affects laboratory use where precise homocysteine measurements are critical for patient care.
The calibrator may not meet the required reference interval due to instability, causing increased positive bias in test results. This can lead to inaccurate homocysteine measurements, potentially affecting patient diagnosis and treatment decisions.
Laboratories using Siemens ADVIA Centaur HCY Calibrator (2 Pack) kits with specific lot numbers are affected. Medical professionals and lab technicians who rely on these calibrators for homocysteine testing are most at risk.
Check the Siemens Material Number 10310376 on the calibrator packaging. Look for lot numbers 86237A74, 44207A75, 25674A77, or 52363A79 on the calibrator or its label.
Verify the lot number on the calibrator packaging to determine if it is affected (86237A74, 44207A75, 25674A77, or 52363A79).
Certain lots of ADVIA Centaur HCY Calibrator have instability that can cause inaccurate homocysteine test results, potentially affecting patient care.
Affected lot numbers include 86237A74, 44207A75, 25674A77, and 52363A79.
No, but you should check the lot number to ensure it is not affected. If it is affected, contact Siemens Healthcare for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1822-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1822-2025 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.
