ARCHITECT 6L22-25Recalls & reported problems
Abbott GmbH · ARCHITECT CORE Reagent Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740011123), received between Dec 13, 2017 and Oct 4, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative 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 Negative Result2
- Low Test Results1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2023False Negative Result; False Negative Result
THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT CORE RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: 24AUG2023: ANTI-HBCORE TOTAL RESULT = 0.08 (NONREACTIVE). ANTI-HBCORE IGM RESULT = 11, REPEAT = 12 (REACTIVE). THE PHYSICIAN IS QUESTIONING THE RESULT SINCE THE ANTI-HBCORE TOTAL RESULT IS LESS THAN THE ANTI-HBCORE M RESULT. THE SAMPLE WAS REPEATED ON 13SEP2023 AND GENERATED THE SAME RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17870991 ↗MalfunctionMay 14, 2018False Negative Result; False Negative Result
THE CUSTOMER OBSERVED A FALSE NEGATIVE HBCORE RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 0.931, REPEATS 4.713, 4.927 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7512743 ↗MalfunctionDec 13, 2017Low Test Results; Low Test Results
THE CUSTOMER IS REQUESTING AN EXPLANATION FOR WHY THE ARCHITECT TOTAL ANTI-HBCORE IS NONREACTIVE ON A PATIENT, BUT THE ARCHITECT ANTI-HBCORE IGM IS REACTIVE. THE RESULTS PROVIDED WERE: ANTI-HBCORE-M =1.62S/CO (>/=1.21S/CO = REACTIVE); AUSAB = >1000. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7113567 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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