Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica IM Cortisol 50T (Material Number 10995538) Recalled by Siemens Healthcare Diagnostics, Inc. Due to There is a negative bias with urine patient...
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
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
Quantity: 34,746 kits
Why Was This Recalled?
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
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