ARCHITECT 1L82-37Recalls & reported problems
Abbott Ireland Diagnostics · ARCHITECT AUSAB Reagent · Class 2
- 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 00380740115371), received between Oct 3, 2018 and Aug 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- False Positive Result2
- High Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2024False Positive Result; High Test Results; False Positive Result; High Test Results
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT AUSAB FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024, SID (B)(6), INITIAL ANTI-HBS= REACTIVE; REPEATED IN DUPLICATE= REACTIVE. THE PATIENT SAMPLE WAS SENT OUT TO A REFERENCE LAB ON (B)(6) 2024, ANTI-HBS CAME BACK NON-REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20048316 ↗MalfunctionOct 3, 2018False Positive Result; False Positive Result
THE CUSTOMER REPORTED ERRATIC AND FALSELY ELEVATED ARCHITECT AUSAB RESULTS. SAMPLE ID (B)(6) WHICH GENERATED MULTIPLE NEGATIVE RESULTS (6.97, 3.65, 3.55 AND 3.98 MIU/ML) AND ONE REACTIVE RESULT OF 69.19 MIU/ML). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7929600 ↗
Other Test, hepatitis b (b core, be antigen, be antibody, b core igm) devices
- Elecsys HBsAg II 08814848190Roche Diagnostics GmbH · Test, hepatitis b (b core, be antigen, be antibody, b core igm)93 reports
- ARCHITECT 4P53-25Abbott Ireland Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall16 reports
- VITROS 6801925Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall15 reports
- ARCHITECT 1L82-27Abbott Ireland Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall4 reports
- VITROS 6801926Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall0 reports
- ARCHITECT 4P54-25Abbott Ireland Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)27 reports
- ADVIA Centaur® HBsII 10492138Siemens Healthcare Diagnostics Inc. · Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)18 reports
- Atellica™ IM HBsII 10995604Siemens Healthcare Diagnostics Inc. · Test, hepatitis b (b core, be antigen, be antibody, b core igm)12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.