Alinity 04V5131Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380740158422), received between Feb 21, 2020 and Feb 17, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Low Test Results

  THE CUSTOMER OBSERVED DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS. ON (B)(6) 2026, SID (B)(6) (2 DAY OLD, MALE) GENERATED ALINITY C TOTAL BILIRUBIN INITIAL RESULT OF 0.4 MG/DL, AND THE RESULT WAS RELEASED. THE RESULT WAS QUESTIONED BY THE PROVIDED. THE SAME SAMPLE WAS REPEATED ON A DIFFERENT ALINITY PROCESSING MODULE 30 MINUTES LATER WITH RESULTS OF 18.6, 18.6 MG/DL. THE SAMPLE REPEATED AGAIN ON THE ORIGINAL ALINITY PROCESSING MODULE OF 18.7 MG/DL. A CORRECTED REPORT SENT OUT TO PROVIDER OF 18.6 MG/DL. THE CUSTOMER DOES NOT HAVE NORMAL RANGE FOR <7 DAYS OLD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369495 ↗
• MalfunctionJan 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.4 ¿ 2.0 MG/DL): ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 5.7 MG/DL, REPEAT RESULT= 1.1 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 3 MG/DL, REPEAT RESULT= 0.5 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 2.3 MG/DL, REPEAT RESULT= 0.2 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 4.3 MG/DL, REPEAT RESULT= 0.7 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 5.7 MG/DL, REPEAT RESULT= 1.1 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 3.5 MG/DL, REPEAT RESULT= 0.3 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 4.4 MG/DL, REPEAT RESULT= 0.8 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 2.8 MG/DL, REPEAT RESULT= 0.4 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 2.1 MG/DL, REPEAT RESULT= 0.3 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 3.7 MG/DL, REPEAT RESULT= 0.5 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 2.4 MG/DL, REPEAT RESULT= 0.4 MG/DL, ON (B)(6) 2025, INITIAL TOTAL BILIRUBIN RESULT= 4.8 MG/DL, REPEAT RESULT= 0.8 MG/DL, ON (B)(6) 2025, INITIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241734 ↗
• MalfunctionJan 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID DATE TIME INITIAL / REPEAT (ANOTHER ALINITY) (B)(6), (B)(6)2024 20:24 16.0 MG/DL; RETEST 1.2 MG/DL, (B)(6), (B)(6) 2024 20:12 3.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), (B)(6)2024 20:01 3.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), (B)(6) 2024 20:00 4.4 MG/DL; RETEST 0.5 MG/DL, (B)(6), (B)(6) 2024 19:59 7.1 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 19:45 15.0 MG/DL; RETEST 2.1 MG/DL, (B)(6), (B)(6) 2024 19:43 7.2 MG/DL; RETEST 0.9 MG/DL, (B)(6), (B)(6) 2024 19:35 7.5 MG/DL; RETEST 0.9 MG/DL, (B)(6), (B)(6) 2024 19:25 14.4 MG/DL; RETEST 1.2 MG/DL, (B)(6), (B)(6) 2024 19:24 4.9 MG/DL; RETEST 0.4 MG/DL, (B)(6), (B)(6) 2024 18:59 5.6 MG/DL; RETEST 0.3 MG/DL, (B)(6), (B)(6) 2024 18:54 5.8 MG/DL; RETEST 0.7 MG/DL, (B)6), (B)(6) 2024 18:43 6.4 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 17:42 6.2 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 17:41 3.9 MG/DL; RETEST 0.4 MG/DL, (B)(6), (B)(6) 2024 17:29 5.8 MG/DL; RETEST 0.5 MG/DL, (B)(6), (B)(6) 2024 17:22 >25.0 MG/DL; RETEST 6.7 MG/DL, (B)(6), (B)(6) 2024 17:19 4.6 MG/DL; RETEST 0.6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166700 ↗
• MalfunctionOct 29, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN2 ON THE ALINITY C PROCESSING MODULE FOR ONE MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE < (B)(6): SID (B)(6), (B)(6) 2024, THE FIRST RUN OF THE SAMPLE GENERATED AN ERROR CODE OF 1041, REACTION CHECK FAILURE ON THE ALINITY SN (B)(6); WHEN REPEATED THE INITIAL BILIRUBIN RESULT= 2 UMOL/L. REPEAT TESTING ON THE ALINITY SN (B)(6) GENERATED THE ERROR CODE 1041 AGAIN; WHEN REPEATED, AFTER RECENTRIFUGATION, RESULTS= 200.1 UMOL/L AND 196.2 UMOL/L. ADDITIONAL RESULTS WERE PROVIDED FOR HISTORICAL/ ADDITIONAL COMPARISON: (B)(6) 2024= 204 UMOL/L, (B)(6) 2024= 209 UMOL/L, (B)(6) 2024= 218 UMOL/L, (B)(6) 2024= 246 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555639 ↗
• MalfunctionOct 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINTY C PROCESSING MODULE FOR TWO SAMPLES. ALSO, INSTRUMENT ERROR MESSAGES WERE OBSERVED ON THE ALINITY C MODULE FOR LINEARITY ERRORS FOR TOTAL BILIRUBIN. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) TBILI <0.1 MG/DL, RE-MEASURED 0.3 MG/DL. SID (B)(6) TBILI <0.1 MG/DL, RE-MEASURED 0.5 MG/DL. NORMAL RANGES TBILI <1.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495169 ↗
• MalfunctionOct 4, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY C TOTAL BILIRUBIN GENERATED FROM AN ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: SAMPLE ID:(B)(6). INITIAL RESULT WAS <0.1 (CUSTOMER NORMAL RANGE IS 0.2 - 1.2 MG/DL) THE SAMPLE WAS REPEATED 3 TIMES ON DIFFERENT ANALYZERS AND GENERATED THE SAME RESULT. THE SAMPLE WAS SENT OUT TO ANOTHER LABORATORY AND GENERATED A RESULT OF 0.2. PATIENT INFORMATION: PATIENT IS PREGNANT AND TAKING PRE-NATAL VITAMINS. 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 20369414 ↗
• MalfunctionJul 23, 2024Low Test Results; Low Test Results

  A JOURNAL ARTICLE BY RAJARSHI SARKAR, MD. ¿A SIMPLE METHOD TO OVERCOME PARAPROTEINEMIC INTERFERENCES IN CHEMISTRY AND IMMUNOASSAYS¿, LABORATORY MEDICINE 2024, NOTED FALSELY DECREASED TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON A 55-YR OLD NORTH INDIAN MALE PATIENT DIAGNOSED WITH MULTIPLE MYELOMA. THE FOLLOWING RESULTS WERE PROVIDED: ALINITY C = 0.1 / 0.2 / 0.1 / 0.4 / / 0.7 MG/DL; VITROS RESULT = 0.4 MG/DL; AU5800 = 0.3 MG/DL; COBAS PURE = 2.38 MG/DL. (REFERENCE RANGE: 0.2-1.1 MG/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804401 ↗
• MalfunctionMar 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN AND PROVIDED THE FOLLOWING DATA FOR A NEWBORN BABY (AGE AND PREMATURE/FULL TERM STATUS UNK): ON (B)(6) 2024 AT 5:35 PM ,SAMPLE ID (B)(6), INITIAL RESULT WAS 389.1 UMOL/L, WHICH GENERATED A HIGH RESULT FLAG. THE CUSTOMER REPORTED THAT BECAUSE OF ELEVATED RESULT PHOTOTHERAPY WAS PROVIDED. AFTER 2 HOURS OF PHOTOTHERAPY, THE CHILD WAS SENT TO ANOTHER FACILITY AND A NEW SAMPLE FOR TOTAL BILIRUBIN (PLATFORM UNKNOWN) GENERATED A RESULT OF 213 UMOL/L. THE PATIENT¿S PHYSICIAN QUESTIONED THE RESULTS AND ASKED TO HAVE SAMPLE ID (B)(6) REPEATED (APPROXIMATELY 14 HOURS LATER). THE REPEAT RESULTS ON (B)(6) 2024 WERE 231.6, 233.8, 244.4 UMOL/L, WHICH ALL RESULTS GENERATED HIGH RESULT FLAGS. THE SAMPLE WAS STORED AT A TEMPERATURE +4°C AND EXPOSED TO ONLY THE LIGHT FROM THE LAB. THERE WERE NO REPORTED INJURIES OR PATIENT HARM AND NO REPORTED IMPACT ON PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913385 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE SAMPLES (MOSTLY PEDIATRIC PATIENT SAMPLES) SINCE THEY SWITCHED TO ALINITY FROM THE VITROS PLATFORM. THE CUSTOMER¿S CURRENT PROTOCOL IS IF A PATIENT HAS A TOTAL BILIRUBIN RESULT OF >18 MG/DL THE PATIENT IS ADMITTED TO THE HOSPITAL. CUSTOMER STATES TECHNOPATH LEVEL 3 WAS REPORTING AT 6.2 AND 6.1 MG/DL, BUT PEER MEAN IS 5.69 MG/DL. CUSTOMER RAN BIORAD PEDI CONTROL, AND IT WAS RECOVERING AT 18.22 MG/DL, BUT THEIR PEER MEAN IS 14.22 MG/DL. QUALITY CONTROL RESULTS ARE STILL WITHIN RANGE BUT ELEVATED. THE CUSTOMER ALSO STATED THEY ARE HAVING TO RE-CALIBRATE THE REAGENT KIT EVERY WEEK TO BRING THE RESULTS AND QC BACK DOWN. THE CUSTOMER PROVIDED ONE EXAMPLE FOR ONE PATIENT SAMPLE RESULTS THAT WERE RUN ON ROCHE AND POC I-STAT PLATFORM PREVIOUSLY AND THEN COMPARED THE RESULTS TO THE RESULT GENERATED ON THE ALINITY C PLATFORM. THE RESULTS WERE FOR THE ONE PATIENT SAMPLE: ON (B)(6)2023 AT 0354 AM ROCHE TOTAL BILIRUBIN RESULT = 13.05 MG/DL ON (B)(6)2023 AT 12:30 PM ROCHE TOTAL BILIRUBIN RESULT = 12.96 MG/DL ON (B)(6)2023 POC I-STAT TOTAL BILIRUBIN RESULT = 16.3 MG/DL ON (B)(6)2023 AT 14:40 PM AT THE CUSTOMER FA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132128 ↗
• MalfunctionMar 31, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT GENERATED ON AN ALINITY C PROCESSING MODULE FOR A (B)(6) BABY BOY. SID (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967639 ↗
• MalfunctionDec 9, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR NEONATES COMPARED TO THE GASOMETER (B)(4), RADIOMETER-SPECTROPHOTOMETRY). THE CUSTOMER PROVIDED THE FOLLOWING FOR FOUR PATIENTS: SID: (B)(6): INITIAL = 15.53 MG/DL, REPEAT 15.96 MG/DL, AND GASOMETER = 11.5 MG/DL; SID: (B)(6): INITIAL = 15.28 MG/DL, REPEATS = 14.92 MG/DL, 13.25 MG/DL(DIL 1:5), 12.43 MG/DL (DIL 1:10), & GASOMETER 11.6 MG/DL; SID: (B)(6): INITIAL = 14.42 MG/DL, AND GASOMETER = 11.2 MG/DL; SID: (B)(6): INITIAL = 15.42 MG/DL, AND GASOMETER = 11.9 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10979262 ↗
• MalfunctionDec 4, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSE DECREASED ALINITY C TOTAL BILIRUBIN RESULT FOR ONE PATIENT. THE CUSTOMER PROVIDED THE CLINICIAN QUESTIONED THE INITIAL RESULT FOR (B)(6) OF 51UMOL/L AS IT DID NOT FIT WITH THE PATIENT HISTORY. THE REPEAT OF 300UMOL/L DOES FIT THE PATIENT HISTORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10946833 ↗
• MalfunctionFeb 21, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULT FOR A PATIENT WITH WALDENSTROMS. SAMPLE ID: (B)(6) GENERATED 33 UMOL/L ON THE ALINITY, 5 UMOL/L ON ROCHE AND 8UMOL/L ON RADIOMETER ABL90. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9740794 ↗