ARCHITECT 8L92-41Recalls & reported problems
Abbott Laboratories · Activated Alanine Aminotransferase · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740017873), received between Apr 5, 2017 and Apr 5, 2017 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Test Results1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2017High Test Results; High Test Results
THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER IS GENERATING FALSELY ELEVATED ALT RESULTS ON A LIVER TRANSPLANT PATIENT. THE RESULTS PROVIDED WERE FROM TWO SAMPLES (SAME PATIENT) TESTED ON DIFFERENT ANALYZERS: (B)(6) 2017 ON C2 ANALYZER (B)(6) - ALT = 16 / ON C3 (SN (B)(4)) (B)(6) - ALT = 86. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6460302 ↗
Other NADH OXIDATION/NAD REDUCTION, ALT/SGPT devices
- Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 08056773190Roche Diagnostics GmbH · NADH OXIDATION/NAD REDUCTION, ALT/SGPT10 reports
- Alanine Aminotransferase acc. to IFCC II 08104697190Roche Diagnostics GmbH · NADH OXIDATION/NAD REDUCTION, ALT/SGPT7 reports
- Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation 20764957322Roche Diagnostics GmbH · NADH OXIDATION/NAD REDUCTION, ALT/SGPT6 reports
- Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation 5850797190Roche Diagnostics GmbH · NADH OXIDATION/NAD REDUCTION, ALT/SGPT3 reports
- ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated 10283341Siemens Healthcare Diagnostics Inc. · NADH OXIDATION/NAD REDUCTION, ALT/SGPT2 reports
- Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 4467388190Roche Diagnostics GmbH · NADH OXIDATION/NAD REDUCTION, ALT/SGPT2 reports
- ARCHITECT 8L92-21Abbott Laboratories · NADH OXIDATION/NAD REDUCTION, ALT/SGPT1 report
- ARCHITECT 7D56-22Abbott GmbH · NADH OXIDATION/NAD REDUCTION, ALT/SGPT1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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