Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in Recalled by Siemens Healthcare Diagnostics, Inc. Due to Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent...
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 Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
Quantity: 731 units US; 16824 units OUS
Why Was This Recalled?
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
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