ARCHITECT 7D81-22Recalls & reported problems
Abbott GmbH · Aspartate Aminotransferase · Class 2
- 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 00380740161811), 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. ON (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 G
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17551435 ↗
Other Nadh oxidation/nad reduction, ast/sgot devices
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 20764949322Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot6 reports
- Aspartate Aminotransferase acc. to IFCC II 08104719190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot5 reports
- Aspartate Aminosransferase acc. to IFCC with pyridoxal phosphate activation 08056838190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot4 reports
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 5850819190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot4 reports
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation 4467493190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot3 reports
- Piccolo AmLyte 13 400-0041Abaxis, Inc. · Nadh Oxidation/Nad Reduction, Ast/Sgot1 report
- Piccolo General Chemistry 13 400-0029Abaxis, Inc. · Nadh Oxidation/Nad Reduction, Ast/Sgot1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.