Alinity 04T9120Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740159528), received between Jul 31, 2024 and Sep 15, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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.

• MalfunctionSep 15, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778619 ↗
• MalfunctionSep 15, 2026High Test Results

  The customer reported a falsely elevated Alinity c Creatinine2 result generated on the Alinity c Processing Module. The questioned creatinine result did not match previous results, and the patient was admitted to the hospital. The following data was provided:(b)(6)2026, SID (b)(6): Initial Creatinine2 result = 2.37 mg/dL (Normal range: 0.72 to 1.25 mg/dL)(b)(6)2026, Repeat Creatinine2 result = 0.70 mg/dL (measured from original sample stored in the refrigerator) There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771439 ↗
• MalfunctionApr 27, 2026Imprecise or Erratic Results

  THE CUSTOMER OBSERVED IMPRECISE ALINITY C CREATININE2 RESULTS GENERATED ON AN ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGES: MALE 0.60 TO 1.30 MG/DL): SID (B)(6) (74 YEAR OLD MALE) INITIAL RESULT ON (B)(6) = 2.37 MG/DL, REPEAT RESULT ON (B)(6) = 1.36 MG/DL SID (B)(6) (80-YEAR-OLD FEMALE) INITIAL RESULT ON (B)(6) = 0.19 MG/DL, REPEAT RESULT ON (B)(6) = 3.39 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010190 ↗
• MalfunctionApr 17, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE2 RESULT ON AN ALINITY C ANALYZER FOR A 28-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.5-1.10 MG/DL): SAMPLE ID (B)(6), INITIAL RESULT WAS 4.01, REPEAT RESULT WAS 0.61 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916406 ↗
• MalfunctionFeb 4, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY C CREATININE RESULTS FOR ON A PATIENT. RESULT WAS NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, SID (B)(6); INITIAL RESULT 1.10 MG/DL. SAMPLE WAS REPEATED ON ANOTHER PROCESSING MODULES AND RESULTS ARE LISTED AS BELOW FOR SAME SID. (B)(6) ,(B)(6), 12:46): 2.21 MG/DL, (B)(6), (B)(6), 13:50): 2.34 MG/DL, (B)(6), (B)(6), 14:31): 2.26 MG/DL, (B)(6), (B)(6), 14:32): 2.23 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262127 ↗
• MalfunctionJan 29, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CREATININE RESULTS FOR A 50-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0.5 - 1.1 MG/DL): SID (B)(6) INITIAL ALINITY C CREATININE RESULT WAS 4.52 MG/DL ((B)(6) 2026). THIS RESULT WAS QUESTIONED BY THE ATTENDING PHYSICIAN. THE SAME SAMPLE WAS MEASURED AGAIN ON (B)(6) 2026: (B)(6): 0.73 MG/DL, (B)(6): 0.78 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208301 ↗
• MalfunctionDec 29, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 ON THE ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.50 ¿ 1.40 MG/DL): (B)(6) 2025, SID (B)(6), 66-YEAR-OLD FEMALE, INITIAL CREATININE RESULT= 2.58 MG/DL; REPEAT RESULT= 0.57 MG/DL. (B)(6) 2025, SID (B)(6), 59-YEAR-OLD MALE, INITIAL CREATININE RESULT= 3.47 MG/DL; REPEAT RESULT= 0.83 MG/DL. (B)(6) 2025, SID (B)(6), 41-YEAR-OLD FEMALE, INITIAL CREATININE RESULT= 5.39 MG/DL; REPEAT RESULT= 1.35 MG/DL. UPDATE, ADDITIONAL PATIENT RESULTS WERE PROVIDED ON 07JAN2026. SID (B)(6), 55-YEAR-OLD MALE, INITIAL CREATINE RESULT= 2.0 MG/DL; REPEAT RESULT= 0.46 MG/DL. SID (B)(6), 79-YEAR-OLD FEMALE, INITIAL CREATINE RESULT= 3.73 MG/DL; REPEAT RESULT= 0.82 MG/DL. SID (B)(6), 64-YEAR-OLD FEMALE, INITIAL CREATINE RESULT= 2.17 MG/DL; REPEAT RESULT= 0.50 MG/DL. SID (B)(6), 47-YEAR-OLD FEMALE, INITIAL CREATINE RESULT= 2.62 MG/DL; REPEAT RESULT= 0.55 MG/DL. SID (B)(6), 73-YEAR-OLD FEMALE, INITIAL CREATINE RESULT= 2.99 MG/DL; REPEAT RESULT= 0.69 MG/DL. SID (B)(6), 81-YEAR-OLD MALE, INITIAL CREATINE RESULT= 4.21 MG/DL; REPEAT RESULT= 1.03 MG/DL. SID (B)(6), 66-YEAR-OLD FEMALE, INITIAL CREATINE RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906618 ↗
• MalfunctionDec 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY C CREATININE RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (72 YEAR OLD MALE PATIENT): INITIAL RESULT WAS <0.06 MG/DL, REPEAT = 3.82 MG/DL. SID (B)(6) (59 YEAR OLD MALE PATIENT): INITIAL RESULT WAS <0.06 MG/DL, REPEAT = 4.43 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681901 ↗
• MalfunctionJun 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE2 ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <1.2 MG/DL): SID (B)(6), INITIAL CREATININE RESULTS= 16.42 MG/DL; REPEAT RESULTS USING A DIFFERENT METHOD AT A DIFFERENT LABORATORY CONFIRMED THE RESULTS. THE PATIENT WAS REFERRED TO THE HOSPITAL AND THE CREATININE WAS REPEATED AND WAS IN NORMAL RANGE USING AN UNKNOWN METHOD (NO ACTUAL RESULT PROVIDED). ADDITIONAL RESULTS WERE PROVIDED: BUN= 279.92 MG/DL; POTASSIUM= 9.88 MMOL/L; CYSTATIN C= 1.25 MG/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166034 ↗
• MalfunctionMay 22, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL RESULT = 3.78 MG/DL, REPEAT RESULT ON SIEMENS EXL = 0.86 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070088 ↗
• MalfunctionMay 14, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 RESULTS GENERATED BY THE ALINITY C PROCESSING MODULE FOR A PATIENT, WHICH WERE INCONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE AND THE ENZYMATIC CREATININE RESULT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025 CREATININE2 RESULTS = 3.36, 3.43, AND 3.44 MG/DL. ON (B)(6) 2025 SID: (B)(6): CREATININE2 RESULT = 3.75 MG/DL. ENZYMATIC CREATININE RESULT = <0.10 MG/DL (REFERENCE RANGE IS 0.72 TO 1.3 MG/DL). OTHER RESULTS PROVIDED: CYSTATIC C RESULT = NORMAL. UREA RESULT = NORMAL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017961 ↗
• MalfunctionApr 30, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CREATININE2 RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON ALINITY C PROCESSING MODULE FOR ONE MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=1.16 MG/DL /REPEATED DUE TO QUESTIONED BY THE PHYSICIAN AT ANOTHER LABORATORY=10.16 MG/DL /REPEATED ON ALINITY ON (B)(6) 2025=10.42 MG/DL LABORATORY REFERENCE RANGE FOR CREATININE=0.60 TO 1.30 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937118 ↗
• MalfunctionMar 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ON FEB 16 IN THE MORNING AN ALINITY C CREATININE2 REAGENT KIT SN (B)(6) WAS LOADED ONTO THE ALINITY C PROCESSING MODULE, LOT 65446UD00, WHICH GENERATED SEVERAL INSTRUMENT ERRORS OF "1039 UNABLE TO CALCULATE THE RESULT. ABSORBANCE EXCEEDED THE OPTICAL LIMIT" PRIOR TO GENERATING THE FALSELY DEPRESSED ALINITY C CREATININE2 RESULTS THAT WERE NOT RELEASED. THE CUSTOMER PROCESSED INTERNAL QUALITY CONTROL WHICH ALSO GENERATED LOW RESULTS. THE CUSTOMER CHANGED THE REAGENT KIT TO SN 06319 AND REPEAT TESTING WAS DONE ON FEB 17, AND IT WAS CONFIRMED THAT THE RESULTS RETURNED TO PERFORM AS EXPECTED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL CREA2 RESULT = < 0.10 MG/DL; REPEAT RESULT = 8.95 MG/DL; SID (B)(6): INITIAL CREA2 RESULT = < 0.10 MG/DL; REPEAT RESULT = 4.68 MG/DL; SID (B)(6): INITIAL CREA2 RESULT = < 0.10 MG/DL; REPEAT RESULT = 2.71 MG/DL. THE CUSTOMER¿S REFERENCE RANGE FOR CREATININE: MALE: 0.80 TO 1.28 MG/DL / FEMALE: 0.55 TO 1.02 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590253 ↗
• MalfunctionDec 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE2 RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A 59-YR OLD PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = 7.0 / 2.74 MG/DL, ANOTHER ALINITY = 2.76 MG/DL. NEW SAMPLE DRAWN IN THE EMERGENCY ROOM AT ANOTHER LABORATORY = 0.7 MG/DL; THIS SAMPLE SID (B)(6) = 0.7 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20949898 ↗
• MalfunctionJul 31, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE, 0.6 - 1.3 MG/DL): SID (B)(6), INITIAL CREATININE RESULT= 8.33 MG/DL (REPORTED); REDRAWN SAMPLE, CREATININE RESULT= 0.94 MG/DL; FIRST SAMPLE, REPEAT RESULTS= 4.35 MG/DL AND 1.8 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19872670 ↗