ARCHITECT 2K41-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 00380740048525), received between Aug 12, 2016 and Sep 29, 2026 — classified as 4 injuries, 370 malfunctions.

The most frequently reported specific device problem is “High Test Results” (290 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 26, 2022Open, Classified

   One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

   Z-1660-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 374 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931652 ↗
• MalfunctionAug 13, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239382 ↗
• MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE ARCHITECT STAT TROPONIN-I RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) 73-YEAR-OLD MALE PROCESSED ON (B)(6) 2026: INITIAL RESULT PROCESSED ON ARCHITECT SERIAL NUMBER (B)(6) = 30 REPEAT 30. SAMPLE WAS THEN PROCESSED ON ARCHITECT SERIAL NUMBER (B)(6) RESULTS = 66 AND 50. SID (B)(6) 55-YEAR-OLD MALE PROCESSED ON (B)(6) 2026: INITIAL RUN ON (B)(6) = 643(NOT REPORTED) REPEAT = <20. REPEATED ON (B)(6) = <20 REDRAW FROM SAME PATIENT = <20 ON BOTH (B)(6). CUSTOMER¿S REFERENCE RANGE = 0-30 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008341 ↗
• MalfunctionApr 17, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), MALE, 53-YEAR-OLD INITIAL RESULT AT 2:30AM WAS 0.358 NG/ML, RERUN FROM SAME INSTRUMENT AT 2:47AM WAS <0.030 NG/ML, RERUN FROM ANOTHER INSTRUMENT AT 3:07AM WAS <0.030 NG/ML. (PATIENT NORMAL RANGE: 0.000 - 0.030 NG/ML) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910841 ↗
• MalfunctionFeb 19, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A 79-YEAR-OLD FEMALE PATIENT. THE LAB REFERENCE RANGE: 0.00 TO 0.04 NG/ML SID (B)(6) (FIRST DRAW): INITIAL RESULT = 0.55 NG/ML. REPEAT RESULT ON THE SAME INSTRUMENT = 0.01 NG/ML. REPEAT RESULT ON ANOTHER INSTRUMENT = 0.001 NG/ML. SID (B)(6) (SECOND DRAW): RESULT = 0.01 NG/ML. SID (B)(6) (THIRD DRAW): RESULT = 0.00 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389897 ↗
• MalfunctionFeb 17, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TROPONIN RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR A 73-YEAR-OLD MALE PATIENT. SID (B)(6) INITIAL RESULT ON ANOTHER ANALYZER (B)(6) = 30 NG/L, REPEAT RESULT ON (B)(6) = 30 NG/L, REPEAT ON (B)(6) = 66 NG/L AND 50 NG/L. THE CUSTOMER¿S REFERENCE RANGE IS 0-30 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367667 ↗
• MalfunctionFeb 12, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT WAS GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S CRITICAL LIMIT: >0.29 NG/ML. SID (B)(6): ON (B)(6) 2026 INITIAL RESULT = 0.48 NG/ML, REPEAT RESULT = 0.02 NG/ML. SID (B)(6) (NEW DRAW): RESULT = 0.03 NG/ML. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323713 ↗
• MalfunctionFeb 11, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT WAS GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A PATIENT WITH A HISTORY OF CORONARY DISEASE THE SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S CRITICAL LIMIT: >0.29 NG/ML. SID (B)(6) (SAMPLE HEMOLYZED WITH HEMOLYSIS INDEX OF 182): (B)(6) 2026 INITIAL RESULT = 0.64 NG/ML, REPEAT RESULT = 0.01 NG/ML SID (B)(6) (NEW DRAW): RESULT = 0.01 NG/ML. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317530 ↗
• MalfunctionJan 9, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE: <=0.03 NG/ML, CRITICAL RANGE: >=0.30 NG/ML. (B)(6) 2025 SID (B)(6) 29-YEAR-OLD FEMALE PATIENT: INITIAL RESULT = 0.82 NG/ML, NEW SAMPLE RESULT = <0.01 NG/ML. ORIGINAL SPECIMEN REPEATED ON THEIR OTHER ANALYZER, AND IT RESULTED = <0.01 NG/ML. (B)(6) 2025 SID (B)(6) 33-YEAR-OLD MALE PATIENT INITIAL RESULT = 0.38 NG/ML, RESULT 2 HOURS LATER = <0.01 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018878 ↗
• MalfunctionJan 6, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I1000SR ANALYZER FOR A 63-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S CUTOFF IS </= 0.4 NG/ML AND CONSIDERED NORMAL NON-CRITICAL): SID (B)(6): ON (B)(6) 2025 AT 4PM: INITIAL TROPONIN RESULT = 0.58 NG/ML (THIS RESULT WAS NOT REPORTED OUT OF THE LAB) REPEATED THE SAMPLE 2 TIMES ON THE SAME ANALYZER AND RESULTS WERE BOTH 0.0 NG/ML A NEW SAMPLE WAS DRAWN ON THE PATIENT LATER IN THE DAY AND TESTED THE TROPONIN-I AND GENERATED A RESULT OF 0.0 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976537 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A 70-YEAR-OLD FEMALE PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. A NEW BLOOD SAMPLE WAS TESTED YIELDED A NORMAL RESULT. THE ORIGINAL SAMPLE WAS THEN RETESTED, ALSO PRODUCING A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: <0.05 NG/ML SID (B)(6) (FIRST DRAW): (B)(6) 2025 @ 05:56 AM INITIAL RESULT = 0.371 NG/ML, REPEAT RESULT = 0.00 NG/ML SID (B)(6) (SECOND DRAW): (B)(6) 2025 @ 08:46AM INITIAL RESULT = 0.00 NG/ML, REPEAT RESULT = 0.00 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881932 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT STAT TROPONIN-I RESULTS. THE CUSTOMER STATED 4 SAMPLES GENERATED ELEVATED ARCHITECT STAT TROPONIN-I RESULTS THAT REPEATED LOWER. AN EXAMPLE WAS PROVIDED: SID (B)(6) (FEMALE, 75 YEARS OLD, IN EMERGENCY DEPARTMENT FOR CHEST PAIN): FIRST DRAW AT 5:25 AM REPORTED AS 0.034 NG/ML. SECOND DRAW AT 6:54 AM REPORTED AS 0.025 NG/ML, REPEATED AS 0.026 NG/ML (SAME ANALYZER), REPEATED OTHER ANALYZER REPORTED AS 0.003 NG/ML. CUSTOMER REFERENCE RANGE: FEMALE 0-0.013 NG/ML, MALE: 0-0.033 NG/ML, CRITICAL BOTH: >=0.3 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759235 ↗
• MalfunctionNov 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TROPONIN RESULT BETWEEN DIFFERENT TUBE TYPES DRAWN AT SAME TIME FROM ONE PATIENT. THE RESULT PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL FROM YELLOW TUBE SPECIMEN=0.075 NG/ML /REPEATED=0.297 NG/ML GREEN TUBE SPECIMEN DRAWN AT SAME TIME= < 0.010 NG/ML /REPEATED= < 0.010 NG/ML THE CUSTOMER CONCERNED FOR THIS GREEN TUBE TYPE SPECIMEN RESULTS/ REDRAWN GREEN TUBE SPECIMEN SID (B)(6) INITIAL=0.029 NG/ML /REPEATED=0.030 NG/ML REDRAWN GREEN TUBE SPECIMEN SID (B)(6) =0.079 NG/ML. YELLOW TUBE SPECIMEN=0.062 NG/ML LABORATORY REFERENCE RANGE FOR TROPONIN= < OR =0.050 NG/ML; > 0.050 NG/ML CONSIDER CARDIAC EVENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497853 ↗
• MalfunctionOct 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT STAT TROPONIN-I RESULT FOR A 45-YEAR-OLD FEMALE PATIENT PRESENTED WITH CHEST PAINS. THE CUSTOMER STATED DUE TO THE CHEST PAINS; A TROPONIN TIME STUDY WAS ACTIVATED WHICH LED TO THE DISCOVERY OF THE FALSE NEGATIVE TROPONIN-I RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): PATIENT INITIAL RUN ON (B)(6) 2025 AT 22:00 = 0.01 (NEGATIVE). PATIENT NEW COLLECTION RUN ON (B)(6) 2025 AT 04:00 AM = 0.26 NG/ML (POSITIVE) (CUSTOMER¿S NORMAL RANGE: 0-0.04 NG/ML). THE POSITIVE RESULT CAUGHT THE ATTENTION OF THE TECH, AND THE TECH PULLED THE INITIAL SAMPLE AND REPEATED THE TEST WHICH GENERATED A POSITIVE RESULT. THE ORIGINAL NEGATIVE RESULT WAS REPORTED TO THE MEDICAL PROVIDER BUT WAS NOTIFIED OF THE CORRECTION WHEN THE NEW SAMPLE WAS TESTED THE NEXT MORNING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417802 ↗
• MalfunctionOct 27, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED ELEVATED ARCHITECT STAT TROPONIN-I FOR A PATIENT AND PROVIDED THE FOLLOWING DATA FOR A 64-YEAR-OLD FEMALE: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 0.22 NG/ML. THE PATIENT HAD ANOTHER DRAW APPROXIMATELY 3 HOURS LATER AND THE RESULT WAS <0.01 NG/ML. THE ORIGINAL SAMPLE WAS THEN REPEATED AND THE RESULT WAS <0.01 NG/ML. CUSTOMER STATED PATIENT DID NOT HAVE ANY IMPROPER TREATMENT. PATIENT HAD 2 EKGS PERFORMED. PATIENT WAS RELEASED FROM ED WITHOUT ISSUE. THERE WAS NO FURTHER REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390439 ↗
• MalfunctionOct 15, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I AND PROVIDED THE FOLLOWING DATA: CUSTOMER TROPONIN CUTTOFF IS 50 UG/L. ON (B)(6) 2025, SID (B)(6) INITIAL RESULT WAS 74 UG/L AND REPEAT RESULT WAS 48 UG/L. PATIENT INFORMATION: 63-YEAR-OLD MALE. THE CUSTOMER CONFIRMED THAT NO PATIENT CARE WAS IMPACTED. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299189 ↗
• MalfunctionSep 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE PATIENT. RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.030-0.118 NG/ML): ON (B)(6) 2025, SAMPLE ID (B)(6); 1ST DRAW RESULTS= 0.013 NG/ML ON (B)(6) 2025, SAMPLE ID (B)(6); 2ND DRAW RESULTS = 0.181, < 0.010 ON THIS INSTRUMENT & < 0.010 ON (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006652 ↗
• MalfunctionAug 18, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.00-0.025 NG/ML): SAMPLE ID (B)(6), INITIAL RESULT WAS 0.0564, REPEAT RESULT WAS <0.01, REPEAT RESULT, USING A NEW SAMPLE, WAS <0.01, REPEAT RESULT, FROM A RED TOP TUBE, WAS <0.01 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834411 ↗
• MalfunctionAug 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT STAT TROPONIN-I. THE RESULT WAS QUESTIONED SINCE IT NOT WAS NOT CONSISTENT WITH THE PATIENT'S SYMPTOMS AND THE CUSTOMER PROVIDED THE FOLLOWING SAMPLE DATA FOR SAMPLE ID (B)(6): ON (B)(6) 2025, INITIAL RESULT WAS 307.7 NG/L (SN: (B)(6)). REPEAT ON ANOTHER ANALYZER AND RESULT WAS 40.4. REPEAT ON ORIGINAL ANALYZER AND RESULT WAS 41.1. CUSTOMER NORMAL REFERENCE RANGE: 0 - 30 NG/L; CRITICAL > 50 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786882 ↗
• MalfunctionAug 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT STAT TROPONIN-I AND PROVIDED THE FOLLOWING SAMPLE DATA FOR SAMPLE ID (B)(6): INITIAL RESULT WAS 109 NG/L (SN: (B)(6)). REPEAT ON ANOTHER ANALYZER (SN (B)(6)) AND RESULT WAS <20. REPEAT ON ORIGINAL ANALYZER (SN: (B)(6)) AND RESULT WAS <20. CUSTOMER NORMAL REFERENCE RANGE: 0 - 30 NG/L; CRITICAL > 50 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786733 ↗
• MalfunctionAug 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 SID: (B)(6) = 0.40 NG/ML, REPEATED SAMPLE ON (B)(6) 2025 = 0.01 NG/ML. (REFERENCE RANGE: 0.00-0.03 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735812 ↗
• MalfunctionAug 1, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A 64-YEAR-OLD FEMALE PATIENT. A SECOND BLOOD DRAW FROM THE PATIENT YIELDED NORMAL RESULTS. IT WAS NOTED THAT THE ARCHITECT STAT TROPONIN-I WAS AN ADD-ON ORDER PLACED TWO HOURS LATER TO SID (B)(6), WHICH WAS DRAWN AT 10:00 AM. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: <0.01 NG/ML. SID (B)(6),(DRAWN AT 10:00 AM): ON (B)(6) 2025 @12:32 PM INITIAL RESULT = 0.136 NG/ML, ON (B)(6) 2025 @15:06 PM REPEAT RESULT = 0.102 NG/ML, ON (B)(6) 2025 @15:36 PM REPEAT RESULT (POST RE-CENTRIFUGE) = 0.000 NG/ML, ON (B)(6) 2025 @15:59 PM REPEAT RESULT (POST RE-CENTRIFUGE) = 0.001 NG/ML, ON (B)(6) 2025 @16:00 PM REPEAT RESULT (POST RE-CENTRIFUGE) = 0.010 NG/ML, ON (B)(6) 2025 @16:00 PM REPEAT RESULT (POST RE-CENTRIFUGE) = 0.003 NG/ML. SID (B)(6),(DRAWN TWO HOURS LATER): ON (B)(6) 2025 @14:48 PM INITIAL RESULT = 0.005 NG/ML, ON (B)(6) 2025 @15:06 PM REPEAT RESULT = 0.008 NG/ML, ON (B)(6) 2025 @15:37 PM REPEAT RESULT = 0.000 NG/ML, ON (B)(6) 2025 @16:01 PM REPEAT RESULT = 0.007 NG/ML, ON (B)(6) 2025 @16:01 PM REPEAT RESULT = 0.000 NG/ML, ON (B)6) 2025 @

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689248 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <0.03 NG/ML): (B)(6) 75-YEAR-OLD FEMALE (B)(6) 2025 RESULT ON I1SR61535 = 2.24 NG/ML, REPEAT RESULT = <0.03 NG/ML. (B)(6) 2025 RESULT ON ANOTHER ARCHITECT I1SR61537 = <0.03 NG/ML. B)(6) 80-YEAR-OLD FEMALE RESULT ON ARCHITECT I1SR61535 = 0.10 NG/ML (B)(6) 2025 INITIAL RESULT ON I1SR61537 = 0.21 NG/ML, REPEAT RESULTS = 0.09 NG/ML, 0.10 NG/ML PREVIOUS RESULT = 0.10 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22595656 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <0.03 NG/ML). (B)(6) 2025 INITIAL RESULT = 0.31 NG/ML, SAMPLE RECENTRIFUGED AND RESULT = <0.01 NG/ML, SAMPLE PATIENT, NEW SAMPLE OBTAINED AND RESULT = <0.01 NG/ML. EKG WAS PERFORMED AND WAS NORMAL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22594811 ↗
• MalfunctionJun 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULTS FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: 0.00-0.04 NG/ML): ON (B)(6) 2025: INITIAL TROPONIN-I RESULT (LITHIUM HEPARIN PLASMA) = 0.46 NG/ML; REPEATED RESULT = 0.30 NG/ML; REPEATED FOR A SECOND TIME = 0.21 AND 0.43 NG/ML. TROPONIN RESULT ON ISTAT WITH THE PLASMA SAMPLE = 0.01 REPEATED RESULT ON ISTAT WITH SERUM SAMPLE = 0.00 CUSTOMER REPORTED OUT THE 0.01 TO THE MEDICAL PROVIDER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196139 ↗