Alinity 07P5720Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00380740132613), received between Mar 2, 2019 and Apr 17, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “High Test Results” (31 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED CALCIUM GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2026, SAMPLE ID (B)(6) INITIAL RESULT WAS 5.8 AND REPEAT RESULT WAS 9.1 (CUSTOMER REFERENCE RANGE IS 8.7 - 10.7 MG/ DL) PATIENT INFORMATION: 85-YEAR-OLD MALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916655 ↗
• MalfunctionMar 4, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE IS MMOL/L, CUSTOMER REFERENCE RANGE IS 2.1 TO 2.6 MMOL/L): SID (B)(6): INITIAL RESULT = 3.41, REPEATS = 3.82, 2.60, 2.60, 2.69 SID (B)(6): INITIAL RESULT = 5.57, REPEATS = 2.41, 2.42 SID (B)(6): INITIAL RESULT = 4.60, REPEATS = 2.39, 2.41 THE CUSTOMER IS QUESTIONING THE FIRST REPEAT RESULT FOR SID (B)(6) AND THE INITIAL RESULTS FOR THE OTHER SIDS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505805 ↗
• MalfunctionJan 23, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C CALCIUM FOR AN 87-YEAR-OLD FEMALE. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: REFERENCE RANGE 2.2 - 2.6 MMOL/L. (B)(6) 2026, SID (B)(6), INITIAL CALCIUM RESULT= 3.61 MMOL/L; REPEAT RESULTS= 2.08 MMOL/L, 2.11 MMOL/L. HISTORICAL RESULT (B)(6) 2026= 2.17 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167120 ↗
• MalfunctionJan 19, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ALINITY C CALCIUM RESULT FOR A 58-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 2.20 TO 2.60 MMOL/L): SID (B)(6): INITIAL RESULT = 1.01 MMOL/L, REPEATS = 2.25 MMOL/L AND 2.26 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108964 ↗
• MalfunctionJul 31, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY C CALCIUM RESULT. (B)(6) 2025, (B)(6) GENERATED CALCIUM OF 3.58 MMOL/L, AUTO RERUN OF 2.38 MMOL/L, REPEATED ON ANOTHER ALINITY OF 2.28 MMOL/L AND 2.33 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679663 ↗
• MalfunctionJun 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 8.0-10.5 MG/DL): (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = 10.6 MG/DL, REPEAT RESULTS = 14.5 MG/DL, 10.5 MG/DL, 10.4 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346062 ↗
• MalfunctionJun 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCREPANT CALCIUM RESULTS GENERATED ON THE ALINITY C ANALYZER. THE RESULTS WERE NOT REPORTED OUT. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID 25450191136 PROCESSED ON 14MAY2025 SAMPLE APPEARANCE HEMOLYZED: RESULTS FROM ALINITY I PROCESSING MODULE SERIAL NUMBER (B)(6) = 4.05, 3.12, 3.22, 2.14. RESULTS FROM ALINITY I PROCESSING MODULE SERIAL NUMBER (B)(6) = 2.05, 2.08. REFERENCE RANGE = 2.2-2.6 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144308 ↗
• MalfunctionMay 28, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C CALCIUM RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 8.4-10.2 MG/DL): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS 4.6, REPEAT RESULT WAS 8.8 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099450 ↗
• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C CALCIUM RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE 8.4-10.2 MG/DL): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS 19.9, REPEAT RESULT WAS 8.9 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567251 ↗
• MalfunctionDec 24, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CALCIUM RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT = 5.3 REPEATED WITH A 10 POINT PRECISION RUN ALL RESULTS 9.4 PATIENT WAS REDRAWN AND RESULT WAS 8.2. REFERENCE RANGE = 8.4-10.2 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21012254 ↗
• MalfunctionAug 22, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR TWO PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT WHICH GENERATED LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 8.8 MG/DL TO 10.2 MG/DL. (B)(6) 2024 (B)(6) ALINITY RESULT = 17.8 MG/DL, REPEAT RESULT ON THE ATLIA = 7.97 MG/DL. (B)(6) 2024 (B)(6) ALINITY RESULT = 23.3 MG/DL, REPEAT RESULT ON THE ATLIA = 7.57 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031233 ↗
• MalfunctionJul 29, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: (B)(6) 2024 SID (B)(6) = 5.54 / 4.59 / 2.14 / 2.09 / 2.10 / 2.30 / 2.08 MMOL/L (NORMAL RANGE: 2.2-2.6 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849379 ↗
• MalfunctionMay 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 8.4-10.2 MG/DL): SAMPLE ID 31782877 INITIAL RESULTS = 0.1 MG/DL, 0.1 MG/DL REPEAT RESULTS = 9.8 MG/DL, 9.8 MG/DL, 9.8 MG/DL, 9.7 MG/DL, 9.8 MG/DL, 9.8 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360929 ↗
• MalfunctionMar 12, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE VALUES 8.4 TO 10.2 MG/DL): 21FEB2024 SID (B)(6).01 INITIAL ALINITY C CALCIUM RESULT 15.3 MG/DL (AC05331), REPEATED ON SAME ANALYZER 9.9 AND 9.7 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887589 ↗
• MalfunctionMar 8, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM (CA) FOR ONE PATIENT ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR CA IS 2.15-2.5 MMOL/L): SAMPLE ID (B)(6) INITIAL CA RESULT, ON (B)(6) 2024, WAS 1.361, REPEAT ON ANOTHER ANALYZER WAS 2.025, REPEAT WITH A DIFFERENT SID, ON (B)(6) 2024, WAS 2.29 MMOL/L; PREVIOUS CA RESULTS ON (B)(6) 2023 WITH SAMPLE ID (B)(6), WERE 1.09, 1.23, 1.44, AND 1.45 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867448 ↗
• MalfunctionJan 30, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED ON TWO OTHER ANALYZERS AND THE RESULTS WERE NORMAL. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 1.03 MMOL/L. REPEATED AT ANOTHER ANALYZER 1 = 2.26 MMOL/L. REPEATED ON ANOTHER ANALYZER 4 = 2.28 MMOL/L. CUSTOMER'S REFERENCE RANGES: 2.10 TO 2.60 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608075 ↗
• MalfunctionDec 12, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL=3.6 MG/DL /REPEATED=9.3 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313661 ↗
• MalfunctionDec 11, 2023High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED ALINITY C CALCIUM RESULTS OF 3.4 AND 4.2 MMOL/L WERE GENERATED FOR A PATIENT SAMPLE (SID (B)(6) THAT RETESTED AT 2.00 AND 1.99 MMOL/L AFTER SAMPLE RE-CENTRIFUGATION. THE CUSTOMER'S NORMAL RANGE IS 2.2 MMOL/L TO 2.6 MMOL/L. THE CUSTOMER DOES NOT BELIEVE THE ISSUE WAS RELATED TO SAMPLE INTEGRITY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307404 ↗
• MalfunctionNov 14, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID:(B)(6), INITIAL RESULT (B)(6) = 2.57 MMOL/L, REPEAT = 3.51 MMOL/L (ABNORMAL CURVE), REPEAT ON ANOTHER ALINITY (B)(6) = 3.72 MMOL/L. THE CUSTOMER PERFORMED A PRECISION TEST ON SID: (B)(6) FOR TROUBLESHOOTING PURPOSES (UNITS OF MEASURE = MMOL/L): ALINITY 1 (B)(6): 2.66, 2.74, 2.73, 2.71, 2.71, 2.61, 2.70, 2.74, 2.88, 2.93. ALINITY 2 (B)(6): 2.51, 2.5, 2.46, 2.49, 2.52, 2.47, 2.48, 2.51, 2.48, 2.55. THE SAMPLE WAS REPEATED AFTER ALIQUOTING THE SAMPLE: ALINITY 1 (B)(6) = 2.34 MMOL/L, ALINITY 2 (B)(6) = 2.31 MMOL/L. A COMPARISON STUDY WAS COMPLETED WITH 30 PATIENT SAMPLES AND NO DISCREPANT RESULTS WERE GENERATED/REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136120 ↗
• MalfunctionAug 31, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 2.25 - 2.75 MMOL/L): SAMPLE ID (B)(4) INITIAL RESULT RAN ON AC02041 = 3.60 MMOL/L, REPEAT = 3.34 MMOL/L, SENT TO ANOTHER LAB AND RESULTS =1.96 MMOL/L, 2.00 MMOL/L ALIQUOT AFTER CENTRIFUGATION RUN ON DIFFERENT PLATFORM AT ANOTHER LAB = 1.79 MMOL/L, 1.79 MMOL/L ALIQUOT AFTER CENTRIFUGATION RUN ON AC02041 = 1.62 MMOL/L, 1.63 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660392 ↗
• MalfunctionAug 16, 2023Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED ALINITY C CALCIUM RESULT OF 0.58 MMOL/L WAS REPORTED FOR A PATIENT. THE CHEMISTRY PATHOLOGIST QUESTIONED THE RESULT, SO THE SAMPLE WAS RETESTED. THE RETEST RESULTS WERE 2.45 AND 2.43 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558375 ↗
• MalfunctionAug 8, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CALCIUM RESULTS (ABOVE NORMAL RANGE) FOR TWO PATIENTS. ONE PATIENT WAS CALLED BACK TO THE EMERGENCY DEPARTMENT FOR A SECOND BLOOD DRAW THAT GENERATED NORMAL RESULTS (NOT PROVIDED). THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) 1ST RUN = 3.258 MMOL/L (B)(6) 2023 12:52 2ND RUN = 4.211 MMOL/L (B)(6) 2023 02:25 3RD RUN = 3.291 MMOL/L (B)(6) 2023 11:45 4TH RUN = 3.232 MMOL/L (B)(6) 2023 11:53 SID (B)(6) 1ST RUN = 3.015 MMOL/L (B)(6) 2023 10:52 2ND RUN = 4.925 MMOL/L (B)(6) 2023 02:23 3RD RUN = 3.955 MMOL/L (B)(6) 2023 11:44 4TH RUN = 3.910 MMOL/L (B)(6) 2023 11:53 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483586 ↗
• MalfunctionAug 3, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2023, SID (B)(6) FROM LITHIUM HEPARIN PLASMA SPECIMEN=4.8 MG/DL THE PATIENT SENDS TO ER DUE TO FALSELY DECREASED ALINITY CALCIUM RESULTS. THE PATIENT WAS REDRAWN AND REPEATED IN ER ON ORTHO=9.3 MG/DL ON (B)(6) 2023, INITIAL SPECIMEN SID (B)(6) REPEATED ON SAME ANALYZER=9.7 MG/DL AND 9.4 MG/DL LABORATORY REFERENCE RANGE FOR CALCIUM=8.6 TO 10.3 MG/DL THE PATIENT DID NOT RECEIVE ANY TREATMENT IN EMERGENCY ROOM. THE PATIENT DISCHARGED FROM EMERGENCY ROOM AFTER RECEIVING NORMAL CALCIUM RESULTS ON ORTHO ANALYZER. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452234 ↗
• MalfunctionJul 13, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. (CUSTOMER PROVIDED EXPECTED RANGE 8.4 -10.2 MG/DL). SID (B)(6) 04JUL2023 ((B)(4)) = 22.0 MG/DL, 16.4 MG/DL, 20.4 MG/DL. REPEATED 05JUL2023 ((B)(4)) = 10.0 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316404 ↗
• MalfunctionMay 2, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 8.4 TO 10.2 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT = 14.31 MG/DL, REPEAT = 9.49 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853594 ↗