Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 08057796190Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336121252), received between Jul 24, 2024 and Sep 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870255 ↗MalfunctionJul 24, 2024Non Reproducible Results; Non Reproducible Results
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR GAMMA-GLUTAMYLTRANSFERASE (GGT) ON TWO COBAS C 503 ANALYTICAL UNITS. THE INITIAL RESULT WAS 91.4 UI/L ON C503 ANALYZER A. THE SAMPLE WAS REPEATED ON C503 ANALYZER A WITH RESULTS OF 55.6 UI/L, 57 UI/L, AND 66 UI/L. THE SAMPLE WAS REPEATED ON C503 ANALYZER B WITH A RESULT OF 91.4 UI/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE REPEAT RESULTS ON C503 ANALYZER B WERE 91.4 UI/L AND 56 UI/L. THE RESULTS CLOSE TO 56 UI/L WERE BELIEVED TO BE CORRECT. ANOTHER SAMPLE FROM THE PATIENT WAS REPEATED 5 TIMES WITH RESULTS OF 51 UI/L AND 52 UI/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19819604 ↗
Other KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE devices
- gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 3002721122Roche Diagnostics GmbH · KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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