ARCHITECT 06R8720Recalls & reported problems
Abbott Ireland Diagnostics · AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test · Class N
All models of ARCHITECT (23)
Data updated Oct 16, 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 00380740191863), received between Dec 4, 2020 and Jan 27, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- False Positive Result2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2021False Positive Result; False Positive Result
THE CUSTOMER OBSERVED A FALSE POSITIVE ADVISEDX SARS-COV-2 IGM RESULT FOR ONE PATIENT, WHO HASN¿T BEEN EXPOSED TO COVID-19, ON AN ARCHITECT I1000SR ANALYZER. THE PATIENT WAS POSITIVE WITH SARS-COV-2 IGM TESTING BUT WAS NEGATIVE WHEN TESTED WITH SARS-COV-2 IGG TESTING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11240348 ↗MalfunctionDec 4, 2020False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT SARS-COV-2 IGM RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: PATIENT = SARS-COV-2 IGM = 1.54 S/C (CUTOFF IS 1.00 S/C); SARS-COV-2 IGG = 4.07 S/C (CUTOFF IS 1.4 S/C) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10945207 ↗
Other Reagent, coronavirus serological devices
- Access SARS-CoV-2 IgG C58961Beckman Coulter, Inc. · Reagent, Coronavirus Serological57 reports
- VITROS 6199976Ortho-Clinical Diagnostics, Inc. · Reagent, coronavirus serological1 recall0 reports
- VITROS 6199960Ortho Clinical Diagnostics · Reagent, coronavirus serological1 recall0 reports
- Access SARS-CoV-2 IgG QC C58964Beckman Coulter, Inc. · Reagent, Coronavirus Serological1 recall0 reports
- Access SARS-CoV-2 IgG II C69057Beckman Coulter, Inc. · Reagent, Coronavirus Serological33 reports
- ARCHITECT 06R8620Abbott Laboratories · Reagent, coronavirus serological16 reports
- Access SARS-CoV-2 IgM C58957Beckman Coulter, Inc. · Reagent, Coronavirus Serological13 reports
- ARCHITECT 06R8630Abbott Laboratories · Reagent, coronavirus serological3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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