ARCHITECT 7D56-22Recalls & reported problems
Abbott GmbH · Alanine Aminotransferase · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740161651), received between Aug 15, 2023 and Aug 15, 2023 — classified as 1 malfunction.
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 Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2023High Test Results; High Test Results
THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) RESULTS WERE GENERATED FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED. (B)(6), 2023 SID (B)(6), ARCHITECT ASPARTATE AMINOTRANSFERASE (AST) RESULT: 302 U/L, ARCHITECT ALANINE AMINOTRANSFERASE (ALT) RESULT: 205 U/L. LATER THE SAME DAY, THE SAME SAMPLE WAS RETESTED. ARCHITECT ASPARTATE AMINOTRANSFERASE (AST) RESULTS: 25, 26 AND 26 U/L, ARCHITECT ALANINE AMINOTRANSFERASE (ALT) RESULTS: 21, 21 AND 21 U/L. A SECOND SAMPLE WAS COLLECTED THE SAME DAY. SID (B)(6), ARCHITECT ASPARTATE AMINOTRANSFERASE (AST) RESULTS: 27 AND 26 U/L, ARCHITECT ALANINE AMINOTRANSFERASE (ALT) RESULTS: 20 AND 20 U/L. A THIRD SAMPLE WAS ALSO COLLECTED. SID (B)(6), ARCHITECT ASPARTATE AMINOTRANSFERASE (AST) RESULT: 25 U/L, ARCHITECT ALANINE AMINOTRANSFERASE (ALT) RESULT: 21 U/L. THE INITIAL ELEVATED RESULTS WERE REPORTED OUT OF THE LAB. ADDITIONAL LABORATORY RESULTS WERE NOT AVAILABLE, BUT THE CUSTOMER STATED THERE WERE NO OTHER ABNORMAL RESULTS. THE PATIENT'S PRESENTING SYMPTOMS WERE NOT AVAILABLE FROM THE CUSTOMER. BASED ON THE ELEVATED AST AND ALT RESULTS, THE PATIENT WAS INDUCED TO GIV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552684 ↗
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 8L92-41Abbott Laboratories · 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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