Siemens Healthcare recalls Atel:lica EPO Assay kits with negative bias risk. Affected lots may give inaccurate results. Contact for remedy details.
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
Siemens Healthcare is recalling Atellica IM Erythropoietin (EPO) Assay kits that may produce inaccurate results due to a negative bias. This could lead to incorrect blood test outcomes if used without correction.
The assay has a consistent negative bias of -35% compared to WHO standards. This means results may be too low, potentially leading to incorrect diagnoses if not corrected.
Users of the Atellica EPO Assay kits for blood testing are affected. Healthcare professionals and labs using the affected lots are most at risk.
Check for Siemens Material Number 10733006 and UDI/DI 00630414245775. Affected lots include 53982039 and 55439041.
Look for lot numbers 53982039 or 55439041 on the kit packaging.
The assay has a negative bias of -35% compared to WHO standards, which may lead to inaccurate results.
Check for lot numbers 53982039 or 55439041 on the kit packaging.
The recall record does not specify a remedy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1280-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1280-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
