ARCHITECT 3L80-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380740005955), received between Jun 24, 2018 and Feb 10, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES. (NORMAL RANGE: 22-29 MEQ/L). THE CUSTOMER REPORTS THE RESULTS OF PATIENTS BEGIN TO INCREASE IN VALUE DURING THE DAY. RESULTS NEAR 35 OR 36 MEQ/L, AFTER CALIBRATING GENERATE NORMAL RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16349807 ↗
• MalfunctionAug 17, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED BICARBONATE (CO2) RESULTS FOR THE PAST MONTH ON PATIENT SAMPLES ON THE ARCHITECT ANALYZER. THE CUSTOMER PROVIDED TWO EXAMPLES OF RESULTS: ON (B)(6) 2020 (B)(6) INITIAL = 40MMOL/L / RETEST TWICE =20MMOL/L (NORMAL RANGE 22-29MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10417521 ↗
• MalfunctionAug 4, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT CO2 ASSAY RESULTS FOR THREE PATIENTS. THE CUSTOMER PROVIDED: (B)(6) INITIAL = >50 MMOL/L, REPEAT = 27 MMOL/L; (B)(6) INITIAL = >50 MMOL/L, REPEAT = 24 MMOL/L; (B)(6) INITIAL = >50 MMOL/L, REPEAT 20.3, 20.4 MMOL/L (RANGE: 23.0 TO 31 MMOL/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10365161 ↗
• MalfunctionJul 20, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CO2 RESULTS ON THE ARCHITECT C4000 ANALYZER FOR TWO PREGNANT PATIENTS. ON (B)(6) 2020 SID (B)(6) RESULT 14 MEQ/L. ON (B)(6) 2020 SID (B)(6) RESULT 15 MEQ/L. THE CUSTOMER'S NORMAL RANGE IS 22 - 32 MEQ/L. VALUES LESS THAN 16 MEQ/L ARE CONSIDERED CRITICAL. BOTH PATIENTS HAD NORMAL ARTERIAL BLOOD GAS CO2 VALUES (21 - 23 MEQ/L). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296192 ↗
• MalfunctionJul 15, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED BICARBONATE (CO2) RESULTS FOR THE PAST MONTH ON PATIENT SAMPLES ON THE ARCHITECT ANALYZER. THE CUSTOMER PROVIDED TWO EXAMPLES OF RESULTS: ON (B)(6) 2020 (B)(6) INITIAL = 40MMOL/L / RETEST TWICE = 20MMOL/L (NORMAL RANGE 22-29MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10276595 ↗
• MalfunctionJan 28, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CO2 RESULTS FOR 7 PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) = 29 / 32 / 33; SID (B)(6) = 23 / 36MEQ/L (NORMAL RANGE 22-29MEQ/L). ON (B)(6) 2020 ADDITIONAL RESULTS PROVIDED: SID (B)(6) = 33 /22; SID (B)(6) = 30 /25; SID (B)(6) = 33 / 22; SID (B)(6) = 33 /25; AND SID (B)(6) = 33 / 22. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638791 ↗
• MalfunctionFeb 5, 2019Low Test Results; Low Test Results

  THE CUSTOMER INQUIRED AS TO WHETHER AN ELEVATED TRIGLYCERIDE RESULT (3642 MG/DL) COULD CAUSE A FALSELY DEPRESSED CO2 RESULT OF 11 MMOL/L FOR A PATIENT SAMPLE TESTED ON THE ARCHITECT C16000 SYSTEM. THE SAMPLE TESTED AT 26 MMOL/L USING AN ALTERNATE CO2 METHOD. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307829 ↗
• MalfunctionDec 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED MULTIPLE ARCHITECT CARBON DIOXIDE RESULTS THAT WERE EITHER FALSELY ELEVATED OR REPEATED LOWER WHEN RERUN. THE CUSTOMER PROVIDED THE FOLLOWING DISCREPANT RESULTS: INITIAL 36, REPEAT 20 DISCREPANT; INITIAL 25, REPEAT 18 DISCREPANT; INITIAL 27, REPEAT 18 DISCREPANT; INITIAL 36, REPEAT 23 DISCREPANT; INITIAL 41, REPEAT 20 DISCREPANT; INITIAL 32, REPEAT 27 DISCREPANT; INITIAL 25, REPEAT 21 DISCREPANT; INITIAL 31, REPEAT 27 DISCREPANT; INITIAL 27, REPEAT 21 DISCREPANT; INITIAL 24, REPEAT 19 DISCREPANT. THE CUSTOMER USES A NORMAL RANGE OF 22-29 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8191268 ↗
• MalfunctionNov 28, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OF FALSELY DEPRESSED ARCHITECT CARBON DIOXIDE RESULTS FOR MULTIPLE SAMPLES. THE CUSTOMER INDICATED THE INITIAL RESULTS WERE APPROXIMATELY 18 MMOL/L AND RETESTED ON A NEW LOT WITH A RESULTS OF APPROXIMATELY 22 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8112107 ↗
• MalfunctionSep 27, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 RESULTS WHILE USING THE CLINICAL CHEMISTRY CO2 ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR 4 PATIENTS (NORMAL RANGE IS 23-31 MEQ/L): SID (B)(6): INITIAL 32 MEQ/L, RETESTED USING NEW REAGENT 27 MEQ/L. SID (B)(6): INITIAL 35 MEQ/L, RETESTED USING NEW REAGENT 29 MEQ/L. SID (B)(6): INITIAL 32 MEQ/L, RETESTED USING NEW REAGENT 27 MEQ/L. SID (B)(6): INITIAL 31 MEQ/L, RETESTED USING NEW REAGENT 27 MEQ/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7914125 ↗
• MalfunctionJul 9, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CO2 RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE FOR 5 SAMPLES: SID (B)(6) = 33.27 / 24.67; SID (B)(6) = 31.89 / 24.26; SID (B)(6) = 31.75 / 23.68; SID (B)(6) = 32.47 / 24.67; SID (B)(6) = 32.87 / 24.52. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7671710 ↗
• MalfunctionJun 28, 2018High Test Results; High Test Results

  THE ACCOUNT OBSERVED ELEVATED ARCHITECT CARBON DIOXIDE RESULTS RANGING 33 TO 35 MMOL/L ON 5 PATIENT SAMPLES. THE SAMPLES WERE REPEATED AFTER RECALIBRATION WITH PATIENT RESULTS IN THE ACCOUNT NORMAL RANGE OF 20 TO 31 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7649241 ↗
• MalfunctionJun 25, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CO2 RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE FOR 5 SAMPLES: SID (B)(6) = 33.27 / 24.67; (B)(6) = 31.89 / 24.26; SID (B)(6) = 31.75 / 23.68; SID (B)(6) = 32.47 / 24.67; SID (B)(6) = 32.87 / 24.52. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634405 ↗
• MalfunctionJun 24, 2018High Test Results; High Test Results

  THE ACCOUNT GENERATED ELEVATED ARCHITECT CARBON DIOXIDE OF 30 MMOL/L ON SID (B)(6) THAT REPEATED 27 MMOL/L AT A REFERENCE LAB. HISTORICAL CARBON DIOXIDE PATIENT RESULTS WERE 28 MMOL/L ((B)(6) 2017), 24 MMOL/L ((B)(6) 2017), 25 MMOL/L ((B)(6) 2017), 28 MMOL/L ((B)(6) 2016). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7632770 ↗