Alinity 04Z2125Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00380740194062), received between Mar 3, 2023 and Sep 16, 2026 — classified as 74 malfunctions.

The most frequently reported specific device problem is “High Test Results” (73 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 25 most recent of 74 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 50794332 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794211 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794208 ↗
• MalfunctionSep 15, 2026High Test Results

  The customer observed elevated Alinity i STAT High Sensitivity Troponin-I results for a 75-year-old patient diagnosed with lung cancer status post left lobectomy in (b)(6) 2026. The patient presented with increased shortness of breath with activities of daily living (ADLs) and sharp pain to left upper quadrant. The patient had an EKG, chest x-ray and pulmonary CT (contrast) completed prior to transferring to the hospital. The following data was provided: (b)(6) 2026, SID: (b)(6). Alinity i STAT High Sensitivity Troponin-I results: 512.2 pg/mL, 548.8 pg/mL, 492.3 pg/mL, 506.8 pg/mL, 506.5 pg/mL,528.3 pg/mL, 521.1 pg/mL. Repeat testing on all instruments remained consistent with the initial findings. The specimen was also tested on the Beckman Access 2 and the result was 11 ng/L (Beckman reference range 16-49 ng/L is Abnormal High). The patient was transferred to ESJ and the Beckman Troponin results at ESJ were 14 ng/L and 15 ng/L. Other results provided: BNP result 607 and 632 pg/mL. There was no negative impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771676 ↗
• MalfunctionSep 9, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698512 ↗
• MalfunctionAug 25, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438067 ↗
• MalfunctionAug 12, 2026High Test Results

  The customer observed a false positive Alinity i Troponin result generated on an Alinity i Processing Module (AI34060) for a 28-year-old male patient. The patient came to the emergency room and Troponin timed studies were ordered. The following data was provided:First timed result SID 26439958 = <2.7 ng/LSecond timed result SID 26440077 = <2.7 ng/LThird timed result SID 26440328 = 62.2 ng/L, repeat on another analyzer (AI34061) = <2.7 ng/LFourth timed result (on AI 34061) SID 26440856 = <2.7 ng/LA corrected report was issued for the 3rd elevated Troponin result. The specimen was hemolyzed on the elevated Troponin; however, the rerun was on the same hemolyzed sample generating the result of <2.7 ng/L. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226841 ↗
• MalfunctionAug 12, 2026High Test Results

  The customer observed elevated Alinity i STAT High Sensitivity Troponin-I results. On 19JUL2026, ID 04262000072A (Female, 55 years old) generated 99.7 ng/L, that repeated <2.7 ng/L (reported out). Customer reference range (ng/L): Normal Female: < 2.7 - 14.0, Critical Female: > 14.0. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226793 ↗
• MalfunctionJul 28, 2026High Test Results

  The customer observed a falsely elevated Alinity i STAT High Sensitivity Troponin-I result for one patient that was not reported out of the laboratory.The following results were provided:(Customer provided reference ranges: Female is 0-13 ng/L and Male 0-34 ng/L)(b)(4)2026 SID (b)(6) 78-year-old female patient: .The customer reported the patient was sent to the cardiac catheterization laboratory due to the patient¿s clinical picture/condition as the patient was having chest pain. The negative result was reported out of the laboratory.No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50051221 ↗
• MalfunctionJul 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50051216 ↗
• MalfunctionJul 13, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS ON MULTIPLE MALE PATIENTS. THE RESULTS PROVIDED WERE:ON (B)(6) 2026 SID (B)(6): INITIAL= 251.0 NG/L /REPEATED ON ALINITY AI21537= <2.7 NG/L /REPEATED ON (B)(6) 2026 ON (B)(6)=3.0 AND <2.7 NG/LREDRAWN AND REPEATED AFTER 2HRS ON ALINITY (B)(6)= <2.7 NG/LREDRAWN AND REPEATED AFTER 4HRS ON ALINITY (B)(6)= <2.7 NG/LSID (B)(6): INITIAL= 232.2 NG/L /REPEATED ON ALINITY AI21537= <2.7 NG/L /REPEATED ON 30JUN2026 ON (B)(6)=<2.7 AND <2.7 NG/LREDRAWN AND REPEATED AFTER 2HRS ON ALINITY AI21531= <2.7 NG/LREDRAWN AND REPEATED AFTER 4HRS ON ALINITY AI21531= <2.7 NG/LLABORATORY REFERENCE RANGE FOR TROPONIN=< 14.0 NG/L; CRITICAL CUTOFF= >200.0 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25797267 ↗
• MalfunctionJul 9, 2026High Test Results

  The customer observed falsely elevated Alinity I STAT High Sensitivity Troponin-I generated from Alinity i Processing Module and provided the following data for an 89-year-old female:Customer reference ranges:Patient normal ranges: 0-14 ng/lCritical High Range: >30 ng/l.Initial sample (SID: (b)(6) result was 6.Second sample (SID: (b)(6) Initial result was103. It was reported that the patient's physician requested a repeat of the same sample after seeing high result. Repeat result on the same analyzer was 7.Third sample (SID: (b)(6) Initial result was 8 and repeat result on the same analyzer was 6. There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765488 ↗
• MalfunctionMay 5, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I FOR A 38-YEAR-OLD MALE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL TROPONIN RESULT= 419.8 PG/ML, THE PATIENT WAS READMITTED AND WENT THROUGH A STRESS TEST AND A 1 HOUR TROPONIN TEST, SID 096108, WITH A RESULT= 6.2 PG/ML. THE INITIAL SAMPLE WAS REPEATED ON (B)(6) 2026 WITH RESULT= 5.7 PG/ML AND AGAIN ON (B)(6) 2026 WITH RESULT= 5.8 PG/ML. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084314 ↗
• MalfunctionApr 16, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS FOR A 60-YEAR-OLD FEMALE PATIENT PRESENTING TO AN URGENT CARE CLINIC WITH CHEST PAIN. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS 441.4, REPEAT RESULT WAS 407.5 PG/ML. A NEW SAMPLE WAS TESTED, SAMPLE ID (B)(6), INITIAL RESULT WAS 451.8, REPEAT RESULT WAS 466.9 PG/ML. THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL EMERGENCY ROOM WHERE THE PATIENT UNDERWENT CARDIAC CATHETERIZATION DUE TO THE ELEVATED RESULTS. THERE WAS NO OBSTRUCTIVE CORONARY ARTERY DISEASE DETECTED DURING THE CORONARY ANGIOGRAPHY. THE PATIENT WAS THEN RETESTED AT THE LOCAL HOSPITAL WITH A BECKMAN ASSAY, AND THE RESULT WAS <3 NG/L, WHICH IS NEGATIVE. IT WAS NOTED THAT THE PATIENT ALSO HAD A 12 LEAD EKG PERFORMED AS WELL AS CHEST AND ABDOMINAL X-RAYS. THERE WAS NO KNOWN IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903986 ↗
• MalfunctionJan 19, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED FOR A 23-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE FOR FEMALE <14 NG/L): (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = 14.2 NG/L, REPEAT RESULT = 3.1 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111584 ↗
• MalfunctionDec 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE 75-YEAR-OLD MALE PATIENT CAME TO THE HOSPITAL WITH SEIZURES. THE PATIENT HAS A MEDICAL HISTORY OF A KIDNEY TRANSPLANT, SEIZURES, HIGH BLOOD PRESSURE, DIABETES AND CHRONIC A-FIB. THE CUSTOMER STATED PRIOR TO THE PATIENT COMING TO THE HOSPITAL HIS DOSE OF ANTI-SEIZURE MEDICATION, KEPPRA, WAS LOWERED. THE PATIENT HAS HAD A SWALLOW STUDY, EKG, CHEST XRAY, AND A CT SCAN WITHOUT IV CONTRAST PERFORMED AS MEDICALLY NECESSARY GIVEN THE PATIENT¿S MEDICAL HISTORY. THE FINDINGS OF THE PROCEDURES DID NOT INDICATE THE PATIENT HAD HEART ISSUES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S CRITICAL CUTOFF IS > 200 NG/L): SAMPLE #1: SID (B)(6) TESTED AT 10:57 = 23.3 NG/L ON ALINITY 2 (B)(6). SAMPLE #2: SID (B)(6) TESTED AT 13:00 = 281 NG/L ON ALINITY 1 (B)(6) ¿ THIS RESULT IS BEING QUESTIONED AS IT DID NOT CORRELATE WITH THE CLINICAL PICTURE SAMPLE #3: SID (B)(6) TESTED AT 17:55 = 61.4 NG/L ON ALINITY 1(B)(6) / 52.0 NG/L ON ALINITY 2 (B)(6). THE CUSTOMER PULLED SAMPLE # 2 FOUR HOURS LATER AND RETESTED IT FOR TROPONIN AND GENERATED RESULTS OF 98.1 NG/L (B)(6) AND 41.3 NG/L (B)(6). THERE WAS NO FURTHER IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864184 ↗
• MalfunctionDec 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED MALE CUTOFF IS >30 NG/L): (B)(6) 2025: INITIAL RESULTS ON BOTH INSTRUMENTS WERE 50 NG/L, REPEAT RESULTS ON BOTH INSTRUMENTS WERE 12 NG/L THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840472 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS. THE PATIENT TESTED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I SID (B)(6) (59 YEAR OLD FEMALE, CAUCASIAN) OF 80 NG/L, AND REPEATED 80 NG/L. THE PATIENT WENT TO ANOTHER HOSPITAL FACILITY AND TESTED ROCHE TROPONIN-T OF 6 NG/L (NEGATIVE). THE OTHER HOSPITAL WAS SENT THE SAME SAMPLE (SID (B)(6)) FOR ROCHE HIGH SENSITIVE TROPONIN-I TESTING, WHICH AGREED WITH THE CUSTOMER LAB RESULTS FOR ALINITY I STAT HIGH SENSITIVITY TROPONIN-I. THE CUSTOMER LAB USES A DIAGNOSTIC CUT OFF IS >60 NG/L. THE PATIENT SPENT OVERNIGHT (1 DAY) IN THE OTHER HOSPITAL FACILITY FOR MONITORING AND DISCHARGED. NO FURTHER INFORMATION REGARDING PATIENT IS AVAILABLE. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758454 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  AN ABSTRACT BY DANIEL KIRCHHOFF, ZACHARY BELDEN, AND DAMODARA MENDU, ¿INVESTIGATION INTO THE PREVALENCE AND CLINICAL IMPACT OF MACROTROPONIN IN AN EMERGENCY DEPARTMENT PATIENT POPULATION¿, CLINICAL CHEMISTRY 71:S1 (2025), NOTED THAT MACROTROPONIN CAN LEAD TO ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE. AMONG 88 EMERGENCY DEPARTMENT PATIENTS WITH TROPONIN RESULT OF >40 NG/L, 16 (18.1%) WERE IDENTIFIED AS MACROTROPONIN-POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657719 ↗
• MalfunctionNov 21, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: CUSTOMER NORMAL RANGE </= 14 NG/L. (B)(6) 2025, INITIAL TROPONIN RESULT= 101 NG/L; REPEAT RESULT= <2.7; REPEAT RESULTS ON OTHER INSTRUMENT= 2.9 NG/L AND 3.2 NG/L. (B)(6) 2025, INITIAL TROPONIN RESULT= 15.1 NG/L; REPEAT RESULT= <2.7 NG/L; REPEAT RESULT ON OTHER INSTRUMENT = <2.7 NG/L. ADDITIONAL PATIENT INFORMATION PROVIDED: SID (B)(6) WAS A 67-YEAR-OLD FEMALE. SID (B)(6) WAS A 52-YEAR-OLD MALE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617960 ↗
• MalfunctionNov 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN THAT AS OCCURRING FOR APPROXIMATELY 2 DAYS. INITIAL CARDIAC ENZYMES WERE NEGATIVE AND THE PATIENT WAS INITIATED ON ANTIPLATELET THERAPY, BETA-BLOCKER, NITRATES AND HEPARIN. THE PATIENT HAD ONE ELEVATED TROPONIN RESULT (244.36 NG/L) AND WAS TAKEN TO THE CARDIAC CATH LAB DUE TO THE ELEVATED RESULT IN COMBINATION WITH THE CHEST PAIN SYMPTOMS. CATH LAB REVEALED MULTIVESSEL CORONARY ARTERY DISEASE INCLUDING SIGNIFICANT OSTIAL LEFT MAIN DISEASE. THE PATIENT WAS TRANSFERRED TO ICU AND WAS TO BE EVALUATED FOR CARDIOVASCULAR SURGERY. IT WAS REPORTED THAT NO PATIENT HARM OCCURRED. THE CUSTOMER PROVIDED THE FOLLOWING LABORATORY DATA: INITIAL TROPONINS WERE NEGATIVE (<2.7 NG/L). CUSTOMER REPORTED SAMPLE ID (B)(6) HAD A TROPONIN RESULT OF 244.36 NG/L. THE CUSTOMER REPEATED THIS SAMPLE 4 TIMES AND GENERATED A RESULTS OF <2.7 NG/L. THE CUSTOMER REPORTED ADDITIONAL PATIENT DISCREPANT TROPONINS: FOR A 66-YEAR-OLD FEMALE PATIENT THE CUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512274 ↗
• MalfunctionNov 6, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS FOR A 75-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: 06OCT2025 SID (B)(6) 4.0 NG/L 18:22. 06OCT2025 SID (B)(6) 133.1 NG/L 19:25, REPEATED ON 07OCT2025 4.5 NG/L 11:40. 07OCT2025 SID (B)(6) 4.0 NG/L 01:51. NORMAL RANGE <14.0 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485729 ↗
• MalfunctionOct 30, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <20 PG/ML): SID (B)(6), INITIAL TROPONIN RESULT (B)(6)= 167.2 PG/ML; REPEAT RESULT (B)(6)= 12.2 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426913 ↗
• MalfunctionOct 6, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE (B)(6) YEAR OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED AND A NEW SAMPLE (SAME PATIENT) WAS PROCESSED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2025 AT 10:00 AM = 436.2 NG/L: REPEAT AT 13:03 ON THE SAME SAMPLE SAME INSTRUMENT = 8.0 NG/L. ISTAT TROPONIN RESULT = 10.5 NG/L. SID (B)(6) SECOND SAMPLE SAME PATIENT RESULT ON (B)(6) 2025 AT 12:09 PM = 6.2 NG/L. CUSTOMER¿S TROPONIN REFERENCE RANGE = 4-16 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221187 ↗
• MalfunctionOct 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND THE RESULTS WERE WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: <3 NG/L SID (B)(6): ON (B)(6) 2025 INITIAL RESULT = 51 NG/L, REPEAT RESULT (SAME ANALYZER) = <3 NG/L, REPEAT RESULT (DIFFERENT ANALYZER) = <3 NG/L, ALL SUBSEQUENT SAMPLES FROM THIS PATIENT WERE <3 NG/L, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199768 ↗