medical Class II Updated 2020-12-30

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usa

Recalled Product

ADVIA 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): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753
View official government recall

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