Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica CH Ethyl Alcohol Recalled by Siemens Healthcare Diagnostics, Inc. Due to The assay may exhibit a positive bias in...
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 CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Quantity: 1124
Why Was This Recalled?
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
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