Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Recalled by Siemens Healthcare Diagnostics, Inc. Due to Siemens Healthcare Diagnostics has confirmed an average negative...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Quantity: 264 units (6 US, 258 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report