ARCHITECT 01G06-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740023089), received between May 29, 2024 and Oct 29, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED POTASSIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL REPORT = 6.5 MMOL/L, REPEAT = 4.8 MMOL/L. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413712 ↗
• MalfunctionApr 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE. RESULTS PROVIDED: 111 / 140 MMOL/L (NORMAL RANGE: 135-145 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871477 ↗
• MalfunctionSep 3, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.72 - 1.25 MG/DL): INITIAL CREATININE RESULT= 14 MG/DL; REPEAT RESULT= 0.71 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127653 ↗
• MalfunctionMay 29, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR TWO PATIENTS. THE CUSTOMER IS USING A NON-ABBOTT MAGNESIUM REAGENT. THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO INSPECT THE INSTRUMENT. THE SAMPLES WERE REPEATED AFTER THE REPAIR AND THE RESULTS WERE NORMAL. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: < 1.02 MMOL/L. SID (B)(6) INITIAL RESULT = >10 MMOL/L, REPEAT RESULT POST REPAIR = 0.76 MMOL/L. SID (B)(6) INITIAL RESULT = >2 MMOL/L, REPEAT RESULT POST REPAIR = 0.87 MMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19418153 ↗