ARCHITECT 2K42-25Recalls & reported problems
Abbott Ireland Diagnostics · ARCHITECT STAT CK-MB Reagent Kit · Class 2
All models of ARCHITECT (23)
Data updated Oct 16, 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 00380740003258), received between Apr 15, 2019 and Apr 15, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- High Test Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CK-MB RESULTS ON TWO PATIENTS. THE RESULTS PROVIDED WERE: PT#1 ON (B)(6) 2019 = 59.9NG/ML / RETEST = 1.6NG/ML (NORMAL RANGE 0-4NG/ML); ON (B)(6) 2019 SID08702797C = 54 / 2.7. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8515431 ↗
Other CALIBRATOR, PRIMARY devices
- ARCHITECT 2K43-25Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall23 reports
- ARCHITECT 2K43-01Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall10 reports
- Access Total T4 Calibrators 33805Beckman Coulter, Inc. · Calibrator, Primary1 recall0 reports
- VITROS 6802344Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, PRIMARY1 recall0 reports
- ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator 10310376Siemens Healthcare Diagnostics Inc. · CALIBRATOR, PRIMARY1 recall0 reports
- VITROS 1112820Ortho Clinical Diagnostics · CALIBRATOR, PRIMARY1 recall0 reports
- HemosIL Heparin Calibrators 00020300600Instrumentation Laboratory Company · CALIBRATOR, PRIMARY1 recall0 reports
- Atellica IM HCY Calibrator 10995498Siemens Healthcare Diagnostics Inc. · Calibrator, primary1 recall0 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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