Siemens Healthcare recalls ADVIA Centaur EPO Assay kits with negative bias affecting test accuracy. Affected lots may produce inaccurate results. Consumers should contact Siemens for 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 ADVIA Centaur E: Erythropoietin (EPO) Assay kits that may produce inaccurate test results due to a negative bias. This could lead to incorrect medical diagnoses if used without correction.
The assay shows a consistent negative bias of -35% compared to WHO standards, meaning results are systematically too low. This could cause false-negative diagnoses if the test is used without adjustment.
Healthcare labs using the affected ADVIA Centaur EPO Assay kits (lots 53984040 and 55443042) are most at risk. Patients relying on these tests for accurate diagnosis may be affected.
Check the kit lot numbers: 53984040 or 55443042. The product is sold under Siemens Material Number 10995096 with UDI/DI 00630414010380.
Look for lot numbers 53984040 or 55443042 on the product label.
The assay shows a consistent negative bias of -35% compared to the WHO International Standard, meaning results are systematically too low.
The reference interval claimed in the Instructions for Use is not achieved with affected lots, potentially leading to false-negative diagnoses.
Contact Siemens Healthcare directly for instructions on how to handle the affected kits.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1281-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1281-2024 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.
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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.
