ARCHITECT 04T0930Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740167578), received between Oct 6, 2025 and Sep 9, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693012 ↗
• MalfunctionJan 29, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN2 RESULTS FOR A 48-HOUR OLD NEWBORN PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA PROVIDED. INITIAL RESULT =18.6 MG/DL, REPEAT RESULTS FROM ROCHE (SEVGI HOSPITAL) =14.6 MG/DL, ROCHE (TRAINING AND RESEARCH HOSPITAL) =15.7MG/DL. REFERENCE RANGE: ABBOTT; 0¿8MG/DL (24 HRS.), 0¿12MG/DL (48 HRS.). REFERENCE RANGE; ROCHE; 0¿8 MG/DL (24 HRS.), 0¿13 MG/DL (48 HRS.). PHYSICIAN ONLY QUESTION RESULTS FOR TOTAL BILIRUBIN. ADDITIONAL DIRECT BILIRUBIN RESULTS PROVIDED. INITIAL RESULT 0.68, REPEAT RESULT (ROCHE) 1.32. REFERENCE RANGE: 0¿0.5 ABBOTT AND 0¿0.58 FROM ROCHE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208456 ↗
• MalfunctionOct 6, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN2 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE ARE UMOL/L): SPECID (B)(6): ORIGINAL RESULT REPORTED OUT = 161, CURRENT CALIBRATOR RESULT = 98.55, NEW CALIBRATOR RESULT = 99.68, NEW CALIBRATOR (RECALIBRATION RESULT) = 99.16 , SPECID (B)(6): ORIGINAL RESULT REPORTED OUT = 96, CURRENT CALIBRATOR RESULT = 67.44, NEW CALIBRATOR RESULT = 68.31, NEW CALIBRATOR (RECALIBRATION RESULT) = 67.15, SPECID (B)(6): ORIGINAL RESULT REPORTED OUT = 150, CURRENT CALIBRATOR RESULT = 122.27, NEW CALIBRATOR RESULT = 122.89, NEW CALIBRATOR (RECALIBRATION RESULT) = 122.68, SPECID (B)(6): ORIGINAL RESULT REPORTED OUT = 197, CURRENT CALIBRATOR RESULT = 139.45, NEW CALIBRATOR RESULT = 139.89, NEW CALIBRATOR (RECALIBRATION RESULT) = 141.32, SPECID (B)(6): ORIGINAL RESULT REPORTED OUT = 195, CURRENT CALIBRATOR RESULT = 156.39, NEW CALIBRATOR RESULT = 155.97, NEW CALIBRATOR (RECALIBRATION RESULT) = 156.68, SPECID (B)(6): ORIGINAL RESULT REPORTED OUT = 39, CURRENT CALIBRATOR RESULT = 9.12, NEW CALIBRATOR RESULT = 8.64, NEW CALIBRATOR (RECALIBRATION RESULT) = 8.58, SPECID (B)(6): ORIGINAL RESULT REPORTED OUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221192 ↗