ARCHITECT 8K28-11Recalls & reported problems
Abbott Laboratories · ARCHITECT BNP Controls · Class 2
All models of ARCHITECT (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740017477), received between Jul 1, 2019 and Jul 22, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- May 24, 2019Terminated
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Z-2079-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- High Test Results2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED NON-ABBOTT AND ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CONTROL LOT 44K78918. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8811897 ↗MalfunctionJul 1, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED ABBOTT CONTROLS SHIFT HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CONTROL LOT 44K80918. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8748288 ↗
Other CALIBRATOR, SECONDARY devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 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 · each recall links to the FDA recall notice
- 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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