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Atellica CH GGT

Siemens Healthcare Diagnostics Inc. · Model 11097597 · UDI-DI 00630414596440

JQA
0
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

G-Glutamyltransferase (GGT) Atellica CH - RGT 1792T

Recalls

DateFirmReason
2020-11-23Siemens Healthcare Diagnostics, Inc.Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatabi
2020-11-23Siemens Healthcare Diagnostics, Inc.Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatabi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.