Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA Centaur PSA Assay Recalled by Siemens Healthcare Diagnostics, Inc Due to PSA assay is not meeting the High Dose...
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 PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
Quantity: 55,754 kits
Why Was This Recalled?
PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report