ARCHITECT 3L82-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740161590), received between Jul 6, 2022 and Feb 27, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low 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.

• MalfunctionFeb 27, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED GLUCOSE RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: 13.14 / 5.87 / 5.90 MMOL/L (REFERENCE RANGE: 3.9-6.11 MMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21477206 ↗
• MalfunctionOct 11, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED GLUCOSE RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE SAME SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: 70 TO 105 MG/DL. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 27.2 MG/DL. REPEATED RESULTS (ON THE SAME INSTRUMENT AND TWO OTHER INSTRUMENTS) = AROUND 160 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911990 ↗
• MalfunctionJan 27, 2023Low Test Results; Low Test Results

  AFTER FURTHER REVIEW, THE FOLLOWING ADDITIONAL SAMPLES WERE IMPACTED DUE TO THE GLUCOSE REAGENT BEING MISREAD BY THE ARCHITECT C16000 PROCESSING MODULE¿S BARCODE READER (RESULTS IN MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS 49, REPEATED RESULT WAS 95. SAMPLE ID (B)(6) INITIAL RESULT WAS 61, REPEATED RESULT WAS 86. SAMPLE ID (B)(6) INITIAL RESULT WAS 50, REPEATED RESULT WAS 87. SAMPLE ID (B)(6) INITIAL RESULT WAS 54, REPEATED RESULT WAS 136. SAMPLE ID (B)(6) INITIAL RESULT WAS 62, REPEATED RESULT WAS 90. SAMPLE ID (B)(6) INITIAL RESULT WAS 70, REPEATED RESULT WAS 86. SAMPLE ID (B)(6) INITIAL RESULT WAS 69, REPEATED RESULT WAS 104. SAMPLE ID (B)(6) INITIAL RESULT WAS 52, REPEATED RESULT WAS 80. SAMPLE ID (B)(6) INITIAL RESULT WAS 57, REPEATED RESULT WAS 101. SAMPLE ID (B)(6) INITIAL RESULT WAS 54, REPEATED RESULT WAS 89. SAMPLE ID (B)(6) INITIAL RESULT WAS 54, REPEATED RESULT WAS 85. SAMPLE ID (B)(6) INITIAL RESULT WAS 63, REPEATED RESULT WAS 95. SAMPLE ID (B)(6) INITIAL RESULT WAS 53, REPEATED RESULT WAS 74. SAMPLE ID (B)(6) INITIAL RESULT WAS 68, REPEATED RESULT WAS 86. SAMPLE ID (B)(6) INITIAL RESULT WAS 68, REPEATED RESULT WAS 81. SAMPLE ID (B)(6) INITIAL RESULT WAS 68, REPEATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254151 ↗
• MalfunctionJul 6, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY REDUCED GLUCOSE RESULT GENERATED ON THE ARCHITECT C16000 ANALYZER ON A PATIENT. RESULTS PROVIDED : SID (B)(6): (B)(6) 2022 INITIAL RESULT 20 MG/DL, REPEAT ON ANOTHER ARCHITECT = 170 MG/DL. REPEATED ON THIS ANALYZER = 167.2 MG/DL AND 175.1 MG/DL.CUSTOMER'S REFERENCE RANGE: 70-135 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935823 ↗