Alinity 08P1925Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380740176525), received between May 15, 2021 and Jul 10, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “High Test Results” (20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781588 ↗
• MalfunctionApr 20, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT ON (B)(6) 2026 AT 1720 >9.5 MG/DL (REPORTED OUT OF THE LAB), REPEATED 1.92 MG/DL (NORMAL RANGE 1.4 TO 2.4 MG/DL). A NEW SAMPLE WAS OBTAINED SID (B)(6) RESULTED (B)(6) 2026 AT 1853 RESULT 1.91 MG/DL. NO SID PROVIDED, INITIAL RESULT >9.5 MG/DL, REPEATED 1.67 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927425 ↗
• MalfunctionMar 17, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C MAGNESIUM (MG) RESULT GENERATED FOR AN 87-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 1.6 - 2.6 MG/DL): SAMPLE ID (B)(6), INITIAL RESULT = 2.7 MG/DL, REPEAT RESULT ON INSTRUMENT (B)(6) = 1.3 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621392 ↗
• MalfunctionFeb 16, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR MULTIPLE PATIENTS WHEN PROCESSED ON THE ALINITY C PROCESSING MODULES. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. ON (B)(6) 2026, 37 YEARS FEMALE: SID: (B)(6); INITIAL RESULT= 7.6 MG/DL, REPEAT RESULT = 2.1 MG/DL. (B)(6). ON (B)(6) 2026, 66 YEARS MALE: SID: (B)(6); INITIAL RESULT (B)(6) = 7.5 MG/DL, REPEAT RESULT = 1.9 MG/DL. (B)(6). ON (B)(6) 2026, SID: (B)(6), INITIAL RESULT =8.1 MG/DL AND REPEAT RESULT =1.8 MG/DL. THE CUSTOMER USE REFERENCE RANGE: 1.6-2.6 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349575 ↗
• MalfunctionFeb 13, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ALINITY C PROCESSING MODULE FOR A 46-YEAR-OLD FEMALE. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER WITH LOWER RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE 1.9 - 2.5 MG/DL): SID: (B)(6), INITIAL MAGNESIUM RESULT= 7.66 MG/DL; REPEAT RESULT ON THE OTHER ANALYZER= 1.51 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337539 ↗
• MalfunctionDec 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM GENERATED FROM ALINITY C PROCESSING MODULE (SN: (B)(6)) THAT REPORTEDLY NORMALIZED UPON REPEAT AND PROVIDED THE FOLLOWING: CUSTOMER NORMAL RANGE IS 1.6 TO 2.6 MG/DL. ON (B)(6) 2025, SAMPLE ID (B)(6): INITIALLY WAS 7.11 AND WHEN REPEATED ON THE SAME ANALYZER, THE RESULT WAS 2.52. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815656 ↗
• MalfunctionNov 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM (MG) RESULTS GENERATED FOR A 4-YEAR-OLD PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 5 MONTHS TO 6 YEARS OLD 0.70 - 0.95 MMOL/L): ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT = 2.98 MMOL/L, REPEAT RESULT = 0.7 MMOL/L, (B)(6) 2025. SAME PATIENT, NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) RESULTS = 2.5 MMOL/L, 0.3 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497072 ↗
• MalfunctionOct 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED BY THE ALINITY C PROCESSING MODULES FOR MULTIPLE PATIENTS. UPON REPEAT TESTING, LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), MAGNESIUM INITIAL RESULT = 3.90 MG/DL (B)(6), REPEAT RESULT = 0.79 MG/DL (B)(6), SID (B)(6), MAGNESIUM INITIAL RESULT = 3.90 MG/DL (B)(6), REPEAT RESULT = 1.03 MG/DL (B)(6), SID (B)(6), MAGNESIUM INITIAL RESULT = 2.57 MG/DL (B)(6), REPEAT RESULT = 0.83 MG/DL, 0.83 MG/DL (B)(6), SID (B)(6), MAGNESIUM INITIAL RESULT = 1.80 MG/DL (B)(6), REPEAT RESULT = 0.84 MG/DL, 0.85 MG/DL (B)(6), SID (B)(6) ,MAGNESIUM INITIAL RESULT = 2.05 MG/DL, REPEAT RESULT = 0.82 MG/DL, SID (B)(6), MAGNESIUM INITIAL RESULT = 1.71 MG/DL (B)(6), REPEAT RESULT = 0.79 MG/DL (B)(6) , SID (B)(6), MAGNESIUM INITIAL RESULT = 1.93 MG/DL (B)(6), REPEAT RESULT = 0.95 MG/DL (B)(6), SID (B)(6), MAGNESIUM INITIAL RESULT = 1.65 MG/DL (B)(6), REPEAT RESULT = 0.87 MG/DL (B)(6). THE CUSTOMER DID NOT PROVIDE MAGNESIUM REFERENCE RANGES, THE APPROXIMATE REFERENCE (NORMAL) RANGE FOR MAGNESIUM IS 1.6 TO 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23198299 ↗
• MalfunctionAug 6, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY C MAGNESIUM RESULTS. SID (B)(6) INITIAL 3.49 REPEAT 0.86 MMOL/L. SID (B)(6) INITIAL 1.07 REPEAT 3.90, 1.08 MMOL/L. SID (B)(6) INITIAL 2.84 REPEAT 0.82 MMOL/L. SID (B)(6) INITIAL 3.90 REPEAT 0.79 MMOL/L. SID (B)(6) INITIAL 3.90 REPEAT 1.03 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731844 ↗
• MalfunctionApr 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED IMPRECISE ALINITY C MAGNESIUM RESULTS. A PATIENT SAMPLE GENERATED ALINITY C MAGNESIUM OF 6 MG/DL THAT REPEATED 1.80 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937974 ↗
• MalfunctionApr 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: SID (B)(6) = 3.905 MMOL/L, REPEATED ON ANOTHER ALINITY = 0.9 / 0.908 / 0.867 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858748 ↗
• MalfunctionMar 17, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.6 TO 2.6 MG/DL): SID (B)(6), INITIAL RESULT= 9.5 MG/DL; REPEAT RESULT= 2.0 MG/DL; REPEAT RESULT (ALTERNATE ANALYZER) = 1.9 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619620 ↗
• MalfunctionSep 26, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED EXPECTED VALUES: 1.6 - 2.6 MG/DL). (B)(6) 2024, SID (B)(6). INITIAL RESULT = 9.04 MG/DL, REPEAT RESULT = 1.97 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310071 ↗
• MalfunctionJan 24, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: MAGNESIUM REFERENCE RANGE (1.6 - 2.6 MG/DL) MAGNESIUM CRITICAL LIMITS (LESS THAN 1.2 MG/DL, HIGH GREATER THAN 3.3 MG/DL) SID (B)(6) INITIAL RESULT WAS 7.3 MG/DL, REPEAT RESULT WAS 2.3 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571310 ↗
• MalfunctionDec 14, 2023High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ALINITY C MAGNESIUM RESULT OF 8 MG/DL WAS GENERATED FOR A PATIENT SAMPLE, ID (B)(6), THAT RETESTED AT 1.5 MG/DL. THE PATIENT WAS REDRAWN AND THE ALINITY C MAGNESIUM RESULT WAS 1.6 MG/DL. THE CUSTOMER'S NORMAL RANGE IS 1.8 - 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330181 ↗
• MalfunctionDec 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 INITIAL RESULT = 6.85 MG/DL, REPEAT ON ANOTHER ALINITY = 1.99 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282405 ↗
• MalfunctionMay 6, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C ANALYZER ON A PATIENT. RESULTS PROVIDED: (B)(6) 2022, SID (B)(6)= 3.90 MMOL/L, ANOTHER ALINITY = 0.75 / 0.76 MMOL/L (NORMAL RANGE: 0.66-1.07 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14305958 ↗
• MalfunctionMar 15, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS. ON (B)(6) 2022 SAMPLE ID (B)(6). GENERATED AN INITIAL RESULT OF 3.35 MMOL/L AND REPEAT OF 0.86 AND 087 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765205 ↗
• MalfunctionMay 24, 2021High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ALINITY C MAGNESIUM RESULT OF 8.685 MG/DL WAS GENERATED FOR PATIENT SAMPLE ID (B)(6) ON (B)(6) 2021. REPEAT TESTING WAS REQUESTED. THE SAME SAMPLE RETESTED AT 1.927, 1.927, 1.902, 1.927, 1.923 AND 1.894 MG/DL. THE CUSTOMER'S NORMAL RANGE IS 1.6 TO 2.6 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872657 ↗
• MalfunctionMay 15, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSE ELEVATED ALINITY C MAGNESIUM RESULT. SAMPLE ID: (B)(4) GENERATED 3.9 MMOL/L AND REPEATS OF 0.97 AND 0.99 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829855 ↗