Alinity 04T7520Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380740150815), received between Feb 21, 2019 and Mar 4, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026High Test Results

  THE CUSTOMER OBSERVED ELEVATED ALINITY I INSULIN RESULTS. (B)(6) 2025: C-PEPTIDE: 22.2 NG/ML, INSULIN: 28.08 UU/ML, GLUCOSE: 117 (NO UNIT OF MEASUREMENT PROVIDED). (B)(6) 2025: C-PEPTIDE: 43.96 NG/ML, INSULIN: 225.7 UU/ML, GLUCOSE: 131. ROCHE ECLIA METHOD: C-PEPTIDE: 38.8 NG/ML, INSULIN: 247.1 UU/ML. (B)(6) 2026: SID (B)(6): C-PEPTIDE: 4.12 NG/ML, INSULIN: 6.4 UU/ML, GLUCOSE: 106. THE PATIENT IS 77-YEAR-OLD, MALE, WITH NO ABNORMALITIES IN GLUCOSE METABOLISM, AND CURRENTLY UNDERGOING TREATMENT FOR STOMACH CANCER, WITH TOTAL GASTRECTOMY PERFORMED IN (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507152 ↗
• MalfunctionJan 6, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR A 77-YEAR-OLD MALE WITH A HISTORY OF GASTRIC CANCER, HYPOGLYCEMIA SECONDARY TO DUMPING SYNDROME (OCTOBER). THE PATIENT WAS UNDER THE METABOLIC MEDICINE DEPARTMENTS CARE FOR POST-OPERATIVE HYPOGLYCEMIC EPISODE (OCTOBER) BUT IS NOT CURRENTLY EXPERIENCING HYPOGLYCEMIA. THE PATIENT DID NOT HAVE ANY FINDINGS IN THE PANCREAS, NOR DID THE PATIENT HAVE INSULIN ADMINISTERED. THE FOLLOWING DATA WAS REPORTED: HISTORICAL RESULTS PROVIDED FROM (B)(6): INSULIN RESULT = 22 UU/ML ON (B)(6) 2025, SID (B)(6): INSULIN RESULT AT 15:16 = 225.7UU/ML (RAW RESULT OF 225.734 UU/ML) INSULIN 1:2 DILUTION RESULT AT 15:53 = 232.6 UU/ML (RESULT VALUE PROVIDED WITHOUT MULTIPLYING THE DILUTION FACTOR OF 2 = 116.3 UU/ML (RAW RESULT OF 116.294 UU/ML)) UNDILUTED INSULIN RESULT AT 16:09 = 228.2 UU/ML (RAW RESULT OF 228.233 UU/ML) OTHER LABORATORY TESTS PROVIDED: CEA RESULT AT 15:15 = 1.45 NG/ML CA 19-9 RESULT AT 15:16 = 14.41 U/ML GLUCOSE LEVELS: PREVIOUS RESULT = 117; CURRENT RESULT (TODAY) = 131 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976164 ↗
• MalfunctionDec 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR ONE PATIENT WHO WAS DIABETIC. THE PATIENT IS TAKING AWIQLI 700 UNITS ONCE A WEEK. THE FOLLOWING DATA WAS PROVIDED: THE INITIAL RESULT FROM (B)(6) 2025 FOR SID (B)(6) WAS >300 UU/ML. THE SAMPLE WAS REPEATED SEVERAL TIMES IN AUTOMATIC DILUTION ON (B)(6) 2025 ON ANOTHER INSTRUMENT (B)(6) AND THE RESULT OBTAINED WAS >600 UU/ML. THE CUSTOMER SENT SAME SAMPLE TO ANOTHER LABORATORY WITH SIEMENS INSTRUMENT OBTAINED THE RESULT OF 18.4 UU/ML. THE PATIENTS¿ BLOOD GLUCOSE WAS 120 MG/DL AND GLUCOSE WAS PRESENT IN URINE. FROM HISTORY TO (B)(6) 2025 THE PATIENT HAD AN ALINITY I INSULIN RESULT OF 10.7 UU/ML. THE PATIENT PROVIDED ANOTHER SAMPLE AND THE ALINITY I INSULIN RESULT FOR SID (B)(6) WAS >600 UU/ML; THE SIEMENS RESULT WAS 8 UU/ML AND THE RESULT OBTAINED FROM ANOTHER LAB (UNKNOWN INSTRUMENT) WAS 8 UU/ML. THE PHYSICIAN ALSO REPORTS THAT LAST MONTH THE PATIENT HAD ELEVATED LEVELS OF PANCREATIC AMYLASE AND LIPASE, DUE TO PANCREATITIS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815685 ↗
• MalfunctionMar 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR A PATIENT WHO IS CURRENTLY UNDER TREATMENT ON OZEMPIC AND DISPLAYED HYPOGLYCEMIA. THE PATIENT REPORTED THEY HAVE NEVER TAKEN INSULIN AND ONLY OZEMPIC. THE FOLLOWING SIDS AND INSULIN DATA RESULTS WERE PROVIDED FOR THE SAME PATIENT: (CUSTOMER PROVIDED REFERENCE RANGE <27 MU/L) ON (B)(6)2025, SID (B)(6), RESULT = 114.76 MU/L, ON (B)(6)2025, SID (B)(6), RESULT = 24.68 MU/L, ON (B)(6) 2025, SID (B)(6), RESULT = >300 MU/L DILUTED, ON (B)(6) 2025, SID (B)(6), RESULT =>600 MU/L, ON (B)(6) 2025, SID (B)(6), RESULT = >300 MU/L DILUTED, ON (B)(6) 2025, SID (B)(6), RESULT = >300 MU/L, ON (B)(6) 2025, SID (B)(6), RESULT = >300 MU/L DILUTED. THE ROCHE RESULT FROM SID (B)(6) = 11.2 MU/ML WITH REFERENCE RANGE OF 2.6-24.9 MU/L. ADDITIONALLY, IT WAS MENTIONED IN ADDITION TO THE OZEMPIC THE PATIENT IS ALSO TAKING THE FOLLOWING MEDICATIONS: COLECALCIFEROL, DICLOFENAC, MAGNESIUM ASPARTATE, MULTIVITAMIN ¿ IRON SULF, FOLIC ACID, PARACETAMOL, PREGABALIN, GLICLAZIDE, AMITRIPTYLINE, MELOXICAM, SEMAGLUTIDE. ADDITIONALLY, IT WAS MENTIONED NO C-PEPTIDE WAS DETECTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517725 ↗
• MalfunctionDec 23, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR ONE 88-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID: (B)(6), INITIAL RESULT = 134.6 UU/ML, 1ST REPEAT RESULT SAME INSTRUMENT = 84.3 UU/ML, 2ND REPEAT RESULT SAME INSTRUMENT = 82.7 UU/ML, REPEAT FROM ANOTHER SAMPLE SAME PATIENT = 66.3 UU/ML. NEW FASTING SAMPLE = 32.7 AND 33.8. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21002230 ↗
• MalfunctionSep 14, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR A PATIENT WITH 2 DIFFERENT SAMPLE DRAWS. THE FOLLOWING DATA WAS PROVIDED FOR SID (B)(6), A 66-YEAR-OLD MALE, DIABETIC/HYPOGLYCEMIA PATIENT NOT USING INSULIN ANALOGS. 02AUG2023; INSULIN RESULTS WERE 896 U/ML AND CLINICAL HISTORY RESULTS WERE ON APRIL 19TH; 593 U/ML, MAY 24TH; 1174 /ML, JUNE 21ST; 720 U/ML. ANOTHER SAMPLE WAS RE-DROWNED AND TESTED ON TOSOH AIA AND THE INSULIN RESULTS WERE 200-300 U/ML. ALINITY RESULTS WITH 1:1 DILUTION; > 300 U/ML, 1:2 DILUTION >600 U/ML. AND MANUAL 896.49 U/ML. THE CUSTOMER USES AN INSULIN REFERENCE RANGE OF 5-10 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746781 ↗
• MalfunctionMar 9, 2023High Test Results; High Test Results

  A LITERATURE ARTICLE BY P. DUFOUR, E. BREVERS, N. PAQUOT, C. LE GOFF, E. CAVALIER, AND A. LANDANG, ¿LABORATORY EXPLORATION OF A VERY HIGH LEVEL OF INSULIN MEASURED IN AN LONG-STANDING TYPE 1 DIABETIC PATIENT¿, CLINICAL CHEMISTRY AND LABORATORY MEDICINE 61.3: EA15-EA16. WALTER DE GRUYTER GMBH. (JAN 2023), DOCUMENTED FALSELY ELEVATED ALINITY I INSULIN RESULTS WHEN COMPARED TO ANOTHER METHOD. THE STUDY NOTED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR A 67 YEAR OLD FEMALE PATIENT WHO WAS DIAGNOSED WITH TYPE 1 DIABETES 50 YEARS AGO. DURING ROUTINE TESTING THE INSULIN RESULTS WERE 11850 PMOL/L AND GLUCOSE RESULTS WERE 159 MG/DL. THE PATIENT DID NOT PRESENT ANY SIGNS OF HYPOGLYCEMIA AND THERAPEUTIC INSULIN OVERDOSE WAS EXCLUDED. THE INSULIN CONCENTRATIONS WERE ALSO MEASURED WITH SIEMENS ATELLICA (1590 PMOL/L) AND ROCHE COBAS (6.74 PMOL/L). THE SAMPLE WAS TREATED WITH VERAPREP WHICH EXCLUDED HETEROPHILIC ANTIBODY INTERFERENCE. MACROINSULIN WAS SUSPECTED AND THE SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL PRECIPITATION (PEG) AND A RECOVERY OF 8% WAS OBSERVED. THE PRESENCE OF ANTI-INSULIN ANTIBODIES WAS ALSO MEASURED WITH ANOTHER MANUFACTURER GENERATING RESULTS OF 16.09 U/ML. NO IMPACT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511721 ↗
• MalfunctionNov 11, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED (B)(6) ALINITY I INSULIN RESULTS ON A NEWBORN BABY. THE INITIAL RESULT ON (B)(6) 2021 FOR SID (B)(4) WAS (B)(6) UU/ML NORMAL ((B)(6) TO (B)(6) UU/ML), THE SECOND SAMPLE SID (B)(4) HAD AN INITIAL RESULT OF (B)(6) UU/ML, REPEATED (B)(6) / (B)(6) / (B)(6) / (B)(6) / (B)(6) / (B)(6) / (B)(6) / (B)(6) UU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797438 ↗
• MalfunctionApr 12, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A PHYSICIAN QUESTIONED FALSELY ELEVATED ALINITY I INSULIN RESULTS ON A FEMALE PATIENT. THE RESULTS PROVIDED WERE: (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649152 ↗
• MalfunctionJan 6, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ALINITY I INSULIN RESULT. SAMPLE ID (B)(6) GENERATED A FLAGGED RESULT OF >3000 UU/ML, DILUTED 1:100 8547.5 UU/ML AND DILUTED 1:200 9093.2 UU/ML. THE SAMPLE WAS TESTED ON ROCHE GENERATING 4 UU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554488 ↗
• MalfunctionFeb 21, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED INSULIN RESULTS ON THE ALINITY ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL 2.7, REPEATS >300 >600, >3,300 COMPARED TO ANOTHER METHOD AS 20-30 UU/ML. A NEW SAMPLE WAS DRAWN AND RESULTS IN 18.9, 15.8 (MATCHING THE OTHER METHOD). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358442 ↗