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

Is my product affected?

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)

• UPC 00630414508344
• UPC 00630414209753

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

What happened

Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent used for in vitro diagnostic testing to measure gamma-glutamyl transferase levels in human samples. The reagent may show a coefficient of variation outside the performance specifications listed in the product's Instructions For Use on some analyzers, which could affect the repeatability and precision of test results at low levels.

The recall affects 397 units in the United States and 1,713 units distributed outside the United States across numerous countries worldwide. All lot codes of the product are affected, including 20 mL bottles (UDI 00630414508344) and 70 mL bottles (UDI 00630414209753). The source document does not specify a remedy for affected consumers.

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: 397 units US; 1713 units OUS Lot/code info: All lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753

Source

Official record: FDA (Device enforcement) ↗

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

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