Alinity 04Z2135Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380740194079), received between Nov 28, 2022 and Sep 16, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “High Test Results” (26 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794333 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791568 ↗
• MalfunctionSep 15, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780513 ↗
• MalfunctionSep 15, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778053 ↗
• MalfunctionSep 10, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717513 ↗
• MalfunctionJul 20, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880452 ↗
• MalfunctionJun 30, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT WHO HAD A NORMAL RESULT AT A DIFFERENT LABORATORY. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGE: <35 NG/L. ALINITY I STAT HIGH SENSITIVITY TROPONIN-I: INITIAL RESULT (B)(6) = 179.6 NG/L REPEAT RESULT ON SECOND INSTRUMENT (B)(6): 165.5 NG/L TROPONIN RESULT FROM ANOTHER FACILITY: 11 (NORMAL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665771 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN I RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR AN 81-YEAR-OLD MALE PATIENT. NO TREATMENT WAS ADMINISTERED, AND THE ELEVATED RESULTS WERE NOT RELEASED FROM THE LABORATORY. THE FOLLOWING INFORMATION WAS PROVIDED (MALE REFERENCE RANGE: < 50 NG/L): SAMPLE ID: (B)(6). ON (B)(6) 2026: THE INITIAL ALINITY I TROPONIN I RESULT WAS 713.8 NG/L. THE PATIENT WAS TRANSFERRED TO A SISTER HOSPITAL, WHERE TROPONIN TESTING WAS PERFORMED ON THE SIEMENS ATELLICA PLATFORM, YIELDING 6.9 NG/L AND 7.2 NG/L. THE ORIGINAL SAMPLE WAS RETESTED ON A SECOND ALINITY I ANALYZER (B)(6), PRODUCING A TROPONIN I RESULT OF 781.98 NG/L. ON 17 FEB 2026, BOTH THE ORIGINAL SAMPLE AND A NEW SAMPLE FROM THE SAME PATIENT WERE REEVALUATED ON THE ALINITY I PLATFORM, WITH RESULTS AGAIN EXCEEDING 600 NG/L. THE ORIGINAL SAMPLE WAS ALSO TESTED ON THE I STAT SYSTEM, WHICH GENERATED A TROPONIN I VALUE OF 7.2 NG/L. THE CUSTOMER ADDITIONALLY TESTED THE SAMPLE COLLECTED AT THE SISTER HOSPITAL, WHICH PRODUCED ANOTHER RESULT ABOVE 600 NG/L ON THE ALINITY I SYSTEM. OVERALL, THE ELEVATED TROPONIN I VALUES OBTAINED FROM THE ALINITY I ANALYZERS DID NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551903 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE 34-YEAR-OLD FEMALE PATIENT WITH CHEST PAIN THAT WAS ADMITTED FOR OBSERVATION DUE TO THE CHEST PAIN. THE SAMPLE AND OTHER SAMPLES WERE THEN RAN WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), PROCESSED ON (B)(6) 2025 AT 10:26 AM = 161 NG/L THIS SAMPLE REPEATED AFTER CENTRIFUGING ON (B)(6) 2025 RESULT = 3 NG/L. THE PATIENT WAS DRAWN TWO OTHER TIMES AFTER INITIAL RESULT WITH BOTH SAMPLE RESULTS = 3 NG/L CUSTOMER¿S TROPONIN REFERENCE RANGE <15 FEMALES NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879433 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. (B)(6) 2025, INITIAL SAMPLE, SID (B)(6) AT 1805 RESULTED 87.7 NG/L, BUT REPEATED <2.7 NG/L. (B)(6) 2025 SECOND SAMPLE, SID (B)(6) AT 1914 RESULTED <2.7 NG/L. THE CUSTOMER REFERENCE RANGE IS <2.7-14 NG/L FOR FEMALES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761430 ↗
• MalfunctionDec 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED FOR A 60-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0 - 14.0 NG/L): SAMPLE ID (B)(6), INITIAL RESULT = 713.0 NG/L, REPEAT RESULT = <3.0 NG/L, REPEAT RESULT ON ANOTHER INSTRUMENT = <3.0 NG/DL, NEW SAMPLE OBTAINED AND RESULT = <3.0 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722960 ↗
• MalfunctionDec 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 64-YEAR-OLD MALE PATIENT. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: NORMAL REF RANGE IS <35 NG/L. SID (B)(6) (FIRST DRAW): (B)(6) 2025 @13:31 TROPONIN-I RESULT = 326 NG/L. (B)(6) 2025 @ 15:55 REPEAT RESULT = 17.8 NG/L. SID (B)(6) (SECOND DRAW AN HOUR LATER): (B)(6) 2025 @ 1535 TROPONIN-I RESULT = 18.4 NG/L. SID NOT PROVIDED (THIRD DRAW): (B)(6) 2025 @ 1611 TROPONIN-I RESULT = 22.1 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717378 ↗
• MalfunctionNov 25, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS FOR FOUR SAMPLES. THE CUSTOMER STATED THAT THE RESULTS WERE FALSELY ELEVATED AND NORMAL UPON REPEAT (NO SPECIFIC PATIENT VALUES WERE PROVIDED). (PATIENT NORMAL RANGES: FEMALES: 3-14 NG/L, MALES: 3-35 NG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647748 ↗
• MalfunctionSep 12, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A 69-YEAR-OLD MALE PATIENT. (CUSTOMER PROVIDED NORMAL REFERENCE RANGE: 3-35 NG/L) THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL RESULT AT 11:37 = 270 NG/L, REPEAT RESULT = <3 NG/L, SAMPLE WAS REPEATED ON OTHER INSTRUMENTS ALL RESULTS = <3 NG/L. SID (B)(6), SECOND DRAW FOR THE SAME PATIENT AT 2:29 PM WITH RESULT = <3 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037616 ↗
• MalfunctionSep 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE IS < 3 NG/L): ON (B)(6) 2025 AT 11:30 AM, SID (B)(6): INITIAL RUN = 81.1 NG/L, PHYSICIAN ORDERED A 2-HOUR TROPONIN-I TEST AND RESULT WAS < 3 NG/L, THE CUSTOMER STATED THE PATIENT SAMPLE FROM 11:30 AM WAS RERUN AND THE RESULT WAS < 3 NG/L ON BOTH INSTRUMENTS. ALL QUALITY CONTROL (QC) WERE IN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 23032058 ↗
• MalfunctionJun 17, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <52 NG/L): ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT = 352.2 NG/L, 20MAY2025 REPEAT RESULT = 15.3 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22230193 ↗
• MalfunctionJun 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE PATIENT ON MELOXICAM PRESENTED WITH CHEST PAIN. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 35 NG/L): ON (B)(6) 2025 AT 16:00, SID (B)(6): INITIAL TROPONIN-I RESULT = 517.7 NG/L (RESULT WAS REPORTED TO THE PHYSICIAN AND THE PHYSICIAN QUESTIONED THE RESULT). REPEAT TROPONIN-I RESULT = < 2.7 NG/L (THIS RESULT WAS OBTAINED FROM BOTH CUSTOMER¿S INSTRUMENTS). THE PATIENT WAS ADMITTED FOR MONITORING FOLLOWING THE INITIAL POSITIVE TROPONIN-I RESULT. THE FOLLOWING TREATMENT WAS GIVEN DUE TO THE FALSE POSITIVE TROPONIN-I RESULT THAT WAS RELEASED TO THE PHYSICIAN: ADMINISTERED PROPHYLAXIS HEPARIN INJECTION. LEFT HEART CATHETERIZATION. RIGHT RADIAL ARTERY CATHETERIZATION. LOVENOX. ASPIRIN. TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 22170200 ↗
• MalfunctionMar 11, 2024High Test Results; High Test Results

  ON 07MAR2024, THE CUSTOMER REPORTED A FEMALE PATIENT WITH FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS USING REAGENT LOT 5819UD00. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE FOR FEMALE PATIENTS IS <15 NG/L CRITICAL HIGH IS >50 NG/L): ON (B)(6) 2024 AT 0055 SID (B)(6) : INITIAL RESULT = 488 NG/L ((B)(6)); REPEAT RESULT ON (B)(6) 2024 AT 0456 = 388.6 NG/L ((B)(6)) ON (B)(6) 2024 AT 0314 SID (B)(6): INITIAL RESULT = < 2.7 NG/L ((B)(6)); REPEAT RESULT ON (B)(6) 2024 AT 0437 = < 2.7 NG/L ((B)(6)) ¿ SAME PATIENT DIFFERENT SAMPLE ON (B)(6) 2024 AT 0402 SID (B)(6): INITIAL RESULT = < 2.7 NG/L ((B)(6)); REPEAT RESULT ON (B)(6) 2024 AT 0438 = < 2.7 NG/L ((B)(6)) ¿ SAME PATIENT DIFFERENT SAMPLE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875063 ↗
• MalfunctionMar 4, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT ON A FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 03:58 PM SID (B)(6) 184.3 NG/L, REPEATED SAME SAMPLE ON ANOTHER ALINITY ON (B)(6) 2024 = < 4 NG/K; NEW SAMPLE ON (B)(6) 2024 17:10 SID (B)(6) = < 4 NG/L. NEW SAMPLE ON (B)(6) 2024 18:26 SID (B)(6) = < 4 NG/L. REFERENCE RANGE: FEMALE <13 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824973 ↗
• MalfunctionFeb 21, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS FOR A 46-YEAR-OLD FEMALE. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE IS <14.0 NG/L): SID (B)(6). (B)(6) 2024 INITIAL RESULT 29.5 NG/L, THE PHYSICIAN QUESTIONED THE RESULT. (B)(6) 2024 REPEATED SAME SAMPLE AND THE RESULT WAS <2.7 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751643 ↗
• MalfunctionFeb 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE FEMALE PATIENT WHILE RUNNING ON THE ALINITY I PROCESSING MODULE. THE QC WAS IN RANGE BEFORE AND AFTER THE DISCREPANT TROPONIN RESULT WAS GENERATED. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE FOR FEMALES IS < 15 NG/L AND CRITICAL HIGH IS > 50 NG/L): SID (B)(6): INITIAL TROPONIN RESULT = 303 NG/L; REPEAT RESULT ON SAME SAMPLE NEXT DAY = < 4 NG/L. THE CUSTOMER STATED 2 MORE SAMPLES FROM THE PATIENT WERE COLLECTED AND TESTED AFTER THE INITIAL SAMPLE AND BOTH SAMPLES GENERATED < 4 NG/L RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18688171 ↗
• MalfunctionDec 28, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: CUSTOMER NORMAL RANGE IS 0-52 NG/L SAMPLE ID (B)(6) INITIAL RESULT WAS 71.7, WHICH WAS QUESTIONED BY PATIENT¿S HEALTHCARE PROVIDER. REPEAT RESULT WAS <5, REPEAT RESULT ON ANOTHER ANALYZER WAS <5. THE CUSTOMER REPORTED THAT TWO SAMPLES WERE COLLECTED AT THE SAME TIME. SAMPLE ID (B)(6) INITIAL RESULT WAS <5, AND REPEAT RESULT WAS <5. THE CUSTOMER REPORTED THAT THEY PERFORMED QC CHECK AFTER THE REPORTED EVENT AND THERE WAS NO ISSUE TO REPORT WITH THE QC CHECK. CUSTOMER STATED THEY HAD A PROBLEM WITH THE PRE TRIGGER LEVEL SENSOR AND REPORTED IT HAS BEEN REPLACED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407581 ↗
• MalfunctionSep 25, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0 PG/ML, REPEAT = 19 PG/ML, REPEAT ON ANOTHER ANALYZER = 0 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814596 ↗
• MalfunctionJul 10, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE PATIENT WHO PRESENTED AT THE HOSPITAL WITH CHEST PAIN. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, AND THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0 TO 14 NG/L. SID 231706758A INITIAL RESULT = > 3600 NG/L; REPEAT RESULTS = 14, 15, 16 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292227 ↗
• MalfunctionMay 16, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A 60-YEAR-OLD MALE WITH SYNCOPE/COLLAPSE, HISTORY OF AFIB, HYPERTENSION, AND TYPE II DM. THE FOLLOWING DATA WAS PROVIDED: 4 DRAWS ON THE SAME PATIENT (RESULTS IN NG/L): 1. SID (B)(6) <4 2. SID (B)(6) 73.351 (REPORTED 4/23 4:20 PM), RERUN IS <4. 3. SID (B)(6) <4 4. SID (B)(6) <4 (CUSTOMER'S REFERENCE RANGE FOR MALE: >/=35, CRITICAL RANGE >200). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942579 ↗