Siemens Healthcare Diagnostics, Inc.: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in

Is my product affected?

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

• UPC 00630414596440

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics, Inc. is recalling its Atellica Gamma-Glutamyl Transferase (GGT) Reagent, a diagnostic test used to measure GGT levels in patient samples. The reagent may show inconsistent results on some analyzers, with a coefficient of variation falling outside the performance specifications listed in the product's instructions. The recall affects all lot codes of this product distributed worldwide, including 731 units in the US and 16,824 units internationally across dozens of countries.

The recall encompasses the UDI 00630414596440 and affects reagent shipments sent to numerous locations including Australia, Canada, Japan, India, Brazil, and European nations. The source document does not specify a remedy or recommended action for affected consumers or healthcare facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zeal Quantity: 731 units US; 16824 units OUS Lot/code info: All lot codes. UDI: 00630414596440

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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