ARCHITECT 01L8684Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740116941), received between Nov 10, 2021 and Jun 3, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT SYPHILIS TP RESULTS ON A PATIENT THAT WAS NONREACTIVE ON THE COBAS PLATFORM. THE RESULTS PROVIDED WERE: ON (B)(6) 2025, SID (B)(6), INITIAL=1.57 S/CO (> OR = 1.00 S/CO=REACTIVE) /REPEATED=1.62 AND 1.21 S/CO /REPEATED ON (B)(6) 2025=1.21 S/CO /ON COBAS 300=0.05 S/CO (NEGATIVE). ADDITIONAL INFORMATION PROVIDED: IMMUNOFLUORESCENCE (ANTI-TP) = NEGATIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134832 ↗
• MalfunctionJan 16, 2025Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER RECEIVED STRONG ELECTRIC SHOCK ON HER LEFT HAND WHEN TRYING TO LOAD AFP REAGENT ON RSH OF ARCHITECT I1000SR PROCESSING MODULE. THE CUSTOMER FEELS TINGLING AND NUMB ON HER ARM. THE ELECTROCARDIOGRAM (EKG OR ECG) PERFORMED ON THE USER ON (B)(6) 2024. THE USER IS DOING OK, AND HER ARM IS OK AND THERE IS NO NUMBNESS. NO FURTHER IMPACT TO PATIENT MANAGEMENT. THERE WAS NO PATIENT INVOLVEMENT OR FACILITY DAMAGE REPORTED.

  Patient problems: Numbness

  MAUDE report 21169166 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR THREE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.00-0.028 NG/ML): SAMPLE ID M INITIAL RESULT, ON 27JUL, WAS 0.034, REPEAT WAS 0.027 NG/ML; PATIENT WAS REDRAWN ON 28JUL, AND THE RESULT WAS 0.14 NG/ML SAMPLE ID A INITIAL RESULT, ON 27JUL, WAS 0.034, REPEAT WAS <0.010, SAMPLE WAS RECENTRIFUGED AND THE REPEAT RESULT WAS 0.019 NG/ML; PATIENT WAS REDRAWN ON 28JUL, AND THE RESULT WAS 0.024 NG/ML. SAMPLE ID M AND A WERE SENT TO A REFERENCE LAB WITH AN ARCHITECT ANALYZER AND THE RESULTS WERE ALL <0.010 NG/ML. THE CUSTOMER RECALIBRATED THE PROBE, RAN CALIBRATION AND QC, AND THE REPEAT RESULTS FOR SAMPLE IDS M AND A WERE <0.010 NG/ML. SAMPLE ID G INITIAL RESULT, ON 29JUL, WAS 0.042, REPEAT WAS 0.013 NG/ML; CUSTOMER PUT ON A NEW REAGENT PACK AND THE RESULT WAS 0.025, REPEAT WAS <0.010 NG/ML; PATIENT WAS REDRAWN, AND THE RESULT WAS 0.016, REPEAT WAS <0.010 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725852 ↗
• MalfunctionSep 1, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE >/= 0.04 NG/ML - POSITIVE, <0.04 NG/ML - NEGATIVE): (B)(6), (B)(6) 2023, INITIAL RESULT = 0.04 NG/ML, REPEAT = 0.03 NG/ML, 0.02 NG/ML. (B)(6), (B)(6) 2023, INITIAL RESULT = 0.4 NG/ML, REPEAT = 0.03 NG/ML, 0.03 NG/ML.(B)(6), (B)(6) 2023,INITIAL RESULT = 0.04 NG/ML, REPEAT = 0.31 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673901 ↗
• MalfunctionSep 1, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON THREE PATIENTS. RESULTS PROVIDED: (B)(6) 2022 SID (B)(6) = 16.959 / 0.012 NG/ML; (B)(6) 2022 SID (B)(6) = 17.212 / 0 NG/ML. (B)(6) 2022 SID (B)(6) = 27.36 / 0.006 / 0.000 NG/ML. NORMAL RANGE: 0.000-0.045 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673531 ↗
• MalfunctionSep 1, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON TWO PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=128.49 NG/L /REPEATED=15.854 NG/L /REPEATED ON ANOTHER ANALYZER=11.055 NG/L. SID = (B)(6) INITIAL=561.252 NG/L /REPEATED=0.000 NG/L /REPEATED ON ANOTHER ANALYZER=0.00 NG/L. LABORATORY NORMAL REFERENCE RANGE = 55 - 74 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671907 ↗
• MalfunctionSep 1, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CLOSE MONITORING. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL REFERENCE RANGE 0.0-0.03 NG/ML). (B)(6) INITIAL SAMPLE RESULT = 0.084 NG/ML. (B)(6) REDRAW RESULT = 0 NG/ML. (B)(6) SECOND REDRAW RESULT = 0 NG/ML. (B)(6) 3350 UNABLE TO PROCESS TEST, ASPIRATION ERROR. (B)(6) 0.002 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0.008 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0.014 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670246 ↗
• MalfunctionSep 1, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE TROPONIN RESULT GENERATED ON AN ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT. THE INITIAL RESULT = 1190 NG/L, REPEAT RESULT = 5.25 NG/L. THE PATIENT WAS REDRAWN, AND THE SAMPLE GENERATED A RESULT = 1.8 NG/L. THE CUSTOMER¿S NORMAL RANGE IS <30 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670147 ↗
• MalfunctionAug 31, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I. THE CUSTOMER REPORTED 3 EVENTS HAVE OCCURRED SINCE (B)(6) 2023 AND REPORTED THAT TWO SAMPLES WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER PROVIDED THE FOLLOWING DATA: (CUSTOMER NORMAL RANGE = 0.0-0.03 NG/ML). ON 26 JULY 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.04, REPEAT RESULT WAS 0.03, REPEAT RESULT ON ANOTHER ANALYZER WAS 0.03. ON 3 AUG 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.05, REPEAT RESULT WAS 0.03, REPEAT RESULT ON ANOTHER ANALYZER WAS 0.03. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662682 ↗
• MalfunctionAug 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE TROPONIN RESULT GENERATED ON AN ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT. THE INITIAL RESULT = 1190 NG/L, REPEAT RESULT = 5.25 NG/L. THE PATIENT WAS REDRAWN, AND THE SAMPLE GENERATED A RESULT = 1.8 NG/L. THE CUSTOMER¿S NORMAL RANGE IS <30 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585810 ↗
• MalfunctionAug 18, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR THREE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.00-0.028 NG/ML): SAMPLE ID M INITIAL RESULT, ON (B)(6) , WAS 0.034, REPEAT WAS 0.027 NG/ML; PATIENT WAS REDRAWN ON (B)(6) , AND THE RESULT WAS 0.14 NG/ML. SAMPLE ID A INITIAL RESULT, ON (B)(6) , WAS 0.034, REPEAT WAS <0.010, SAMPLE WAS RECENTRIFUGED AND THE REPEAT RESULT WAS 0.019 NG/ML; PATIENT WAS REDRAWN ON (B)(6) , AND THE RESULT WAS 0.024 NG/ML. SAMPLE ID M AND A WERE SENT TO A REFERENCE LAB WITH AN ARCHITECT ANALYZER AND THE RESULTS WERE ALL <0.010 NG/ML. THE CUSTOMER RECALIBRATED THE PROBE, RAN CALIBRATION AND QC, AND THE REPEAT RESULTS FOR SAMPLE IDS M AND A WERE <0.010 NG/ML. SAMPLE ID G INITIAL RESULT, ON 29JUL, WAS 0.042, REPEAT WAS 0.013 NG/ML; CUSTOMER PUT ON A NEW REAGENT PACK AND THE RESULT WAS 0.025, REPEAT WAS <0.010 NG/ML; PATIENT WAS REDRAWN, AND THE RESULT WAS 0.016, REPEAT WAS <0.010 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577350 ↗
• MalfunctionMar 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE >/= 0.04 NG/ML - POSITIVE, <0.04 NG/ML - NEGATIVE): SAMPLE ID (B)(6) (B)(6) 2023 INITIAL RESULT = 0.04 NG/ML, REPEAT = 0.03 NG/ML, 0.02 NG/ML. SAMPLE ID (B)(6) (B)(6) 2023 INITIAL RESULT = 0.4 NG/ML, REPEAT = 0.03 NG/ML, 0.03 NG/ML. SAMPLE ID (B)(6) (B)(6) 2023 INITIAL RESULT = 0.04 NG/ML, REPEAT = 0.31 NG/ML . NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629840 ↗
• MalfunctionMar 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CLOSE MONITORING. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL REFERENCE RANGE 0.0-0.03 NG/ML). ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) INITIAL SAMPLE RESULT = 0.084 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) REDRAW RESULT = 0 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) SECOND REDRAW RESULT = 0 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 3350 UNABLE TO PROCESS TEST, ASPIRATION ERROR. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 0.002 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 0 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 0.008 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 0 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 0 NG/ML. ON (B)(6) 2023 SID 1732 (SN (B)(6)) 0.014 NG/ML. ON (B)(6) 2023 SID 1840 (SN (B)(6)) 0 NG/ML. ON (B)(6) 2023 SID (B)(6) (SN (B)(6)) 0 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583288 ↗
• MalfunctionFeb 4, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON TWO PATIENTS. RESULTS PROVIDED: (B)(6) 2022 SID (B)(6) = 16.959 / 0.012 NG/ML; (B)(6) 2022 SID (B)(6) = 17.212 / 0 NG/ML. NORMAL RANGE: 0.000-0.045 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455793 ↗
• MalfunctionNov 10, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON TWO PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B(6) INITIAL=128.49 NG/L /REPEATED=15.854 NG/L /REPEATED ON ANOTHER ANALYZER=11.055 NG/L. SID = (B)(6) INITIAL=561.252 NG/L /REPEATED=0.000 NG/L /REPEATED ON ANOTHER ANALYZER=0.00 NG/L LABORATORY NORMAL REFERENCE RANGE = 55 - 74 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790215 ↗