Alinity 08P1934Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380740176532), received between Nov 9, 2021 and Nov 17, 2025 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “High Test Results” (26 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C MAGNESIUM RESULT FOR AN 80-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 1.6 TO 2.3 MG/DL): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 8.3 MG/DL, REPEAT ON ANOTHER ALINITY = 2.0 MG/DL THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567619 ↗
• MalfunctionDec 20, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE OBSERVED (REFERENCE RANGE: 0.70-1.10 MMOL/L): 29OCT2024, SID (B)(6), INITIAL MAGNESIUM RESULT= 3.876 MMOL/L; REPEAT RESULT= 0.90 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988772 ↗
• MalfunctionAug 30, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM (MG) RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE UPPER LIMIT 1.07 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 2.89 MMOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT AC1699 = 0.73 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107748 ↗
• MalfunctionJun 13, 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: (B)(6) 2024 SID (B)(6) INITIAL RESULT = 2.650 MMOL/L, REPEAT RESULT = 0.873 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529185 ↗
• MalfunctionApr 23, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM GENERATED FROM A ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE FOR MAGNESIUM IS 1.6 TO 2.6 MG/DL. ON 5 APR 2024, SAMPLE ID (B)(6) GENERATED MAGNESIUM RESULT OF 7.84 MG/DL, WHICH WAS REPORTEDLY FLAGGED AS A CRITICAL RESULT. THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 1.72, 1.69, 1.75. TROUBLESHOOTING WAS PERFORMED, WHICH INVOLVED ANALYZER ADJUSTMENTS AND REPLACING AN ANALYZER PART. PRECISION WAS RAN WITH 10 HIGH AND 10 LOW SAMPLES, WHICH ALL GENERATED RESULTS IN THE ACCEPTABLE RANGE. ADDITIONAL LABORATORY VALUES PROVIDED: SODIUM WAS 137.8 & 138.4 MMOL/L, PHOSPHORUS WAS 3.5 & 3.5 MG/DL, TOTAL PROTEIN WAS 7.14 & 7.15 G/DL, UREA WAS 15.6 & 15.7 MG/DL. PER THE CUSTOMER THE DISCREPANT RESULT(S) WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167551 ↗
• MalfunctionDec 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED WHICH WAS NOT REPORTED OUT OF THE LAB: SID (B)(6)PROCESSED ON (B)(6)2023 INITIAL MAGNESIUM RESULT = 3.44 MMOL/L REPEAT 0.53 MMOL/L REFERENCE RANGE = 0.66-1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302043 ↗
• MalfunctionOct 30, 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 SID (B)(6) INITIAL RESULT = 6.35 MMOL/L, REPEAT ON AN ARCHITECT = 0.86 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029935 ↗
• MalfunctionSep 11, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRATIC MAGNESIUM RESULTS GENERATED FROM AN ALINITY C PROCESSING MODULE (SN: AC02156) AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT. (CUSTOMER NORMAL RANGE 1.5 -2.5 MG/DL ON (B)(6) 2023 SAMPLE ID(B)6) GENERATED A RESULT OF 0.99 AND REPEAT RESULTS WERE 1.03 AND 1.0. REPEATED ON ANOTHER ALINITY C PROCESSING MODULE (SN: AC02157) GENERATED A RESULT OF 1.59. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725707 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6)2023 SID (B)(6)INITIAL=3.29 MMOL/L /REPEATED=0.70 AND 0.69 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720940 ↗
• MalfunctionAug 30, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 2.54 / 0.86 / 0.85 MMOL/L (NORMAL RANGE: 0.7-1.0 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649232 ↗
• MalfunctionAug 22, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON AN ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS THAT REPEATED NORMAL ON ANOTHER ALINITY. THE FOLLOWING RESULTS WERE PROVIDED (NORMAL RANGE 1.6 ¿ 2.6 MG/DL): SID (B)(6) INITIAL RESULT = >9.50 MG/DL; REPEAT RESULT = 2.50 MG/DL. SID (B)(6) INITIAL RESULT = 6.01 MG/DL; REPEAT RESULT = 2.05 MG/DL. SID (B)(6) INITIAL RESULT = 9.50 MG/DL; REPEAT RESULT = 1.89 MG/DL. SID (B)(6) INITIAL RESULT = >9.50 MG/DL; REPEAT RESULT = 1.98 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596243 ↗
• MalfunctionAug 14, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED FROM AN ALINITY C PROCESSING MODULE ON 23 JULY 2023. THE CUSTOMER REPORTED THAT HEALTHCARE PROVIDERS HAVE QUESTIONED THE RESULTS AND WHEN REPEATED, THE ELEVATED RESULTS WERE NORMAL. THE CUSTOMER PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE IS 1.6- 2.6 NG/DL SAMPLE ID (B)(6) INITIAL RESULT WAS 6.2 AND REPEAT ON ANOTHER ANALYZER WAS 2.4. SAMPLE ID (B)(6) INITIAL RESULT WAS 6.0 AND REPEAT ON ANOTHER ANALYZER WAS 1.9. SAMPLE ID (B)(6) INITIAL RESULT WAS 6.0 AND REPEAT ON ANOTHER ANALYZER WAS 1.5. SAMPLE ID (B)(6) INITIAL RESULT WAS 6.0 AND REPEAT ON ANOTHER ANALYZER WAS 2.5. THE CUSTOMER PERFORMED SOME TROUBLESHOOTING, SUCH AS CHANGING PROBES ON THE ANALYZER AND AFTERWARDS PERFORMED A PRECISION STUDY ON A SAMPLE THAT REPORTED AT 1.8. THE PRECISION RESULTS WERE 8.3, 2.2, 1.7, 1.6, 1.6, 1.7, 1.6, 1.8, 2.0, 1.7. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547474 ↗
• MalfunctionJul 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULT GENERATED FROM AN ALINITY C PROCESSING MODULE ON (B)(6) 2023 AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: (REFERENCE RANGE: 0.66 TO 1.07 MMOL/L) SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER SN:(B)(6) WAS 2.89 MMOL/L. REPEAT RESULT ON ANOTHER ALINITY C PROCESSING MODULE (SN: (B)(6)) WAS 0.56 MMOL/L. REPEAT ON THE ORIGINAL ANALYZER SN: (B)(6) WAS 0.52 MMOL/L THE CUSTOMER THEN PERFORMED A 10 REPEAT TESTING OF THE PATIENT SAMPLE ON THE ORIGINAL ANALYZER SN:(B)(6) ON (B)(6) 2023, WHICH GENERATED THE FOLLOWING RESULTS: 0.54, 0.54, 0.55, 0.54, 0.54, 0.54, 0.55, 0.56, 0.53, 0.56 THE CUSTOMER REPORTED THAT THE DISCREPANT RESULT WAS NOT REPORTED TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370650 ↗
• MalfunctionMay 3, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR ONE PATIENT ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.7-1.10 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT, ON 15APR, WAS 2.48, REPEAT WAS 0.83 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863506 ↗
• MalfunctionMar 4, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C MAGNESIUM RESULT FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT. THE SAMPLE WAS REPEATED AND THE RESULT WAS HIGHER. THE FOLLOWING DATA WAS PROVIDED PROCESSED ON 14FEB2023: SID (B)(6) INITIAL RESULT = 0.48 REPEAT RESULT = 1.12. REFERENCE RANGE = 0.66 TO 1.07 MMOL/L NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483458 ↗
• InjuryFeb 23, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED MAGNESIUM RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON ALINITY C PROCESSING MODULE FOR SEVERAL PATIENTS. THE CUSTOMER STATED 8 PATIENTS GIVEN MEDIAL TREATMENT 2G MAGNESIUM IN 50ML SALINE INTRAVENOUSLY BASED ON INITIAL MAGNESIUM RESULTS. THE QUALITY CONTROLS OUT OF RANGES BEFORE GENERATING THE DISCREPANT MAGNESIUM RESULTS. THERE WERE NO ACTUAL RESULTS PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THOSE PATIENTS RECEIVED MAGNESIUM TREATMENT. LABORATORY REFERENCE RANGE FOR MAGNESIUM=1.8 TO 2.6 MG/DL; CRITICAL LOW=0.9 MG/DL; HIGH=4.9 MG/DL NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16428899 ↗
• MalfunctionDec 24, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0.66 TO 1.07 MMOL/L): SAMPLE ID (B)(6); INITIAL RESULT = 2.69 MMOL/L, REPEAT = 0.84 MMOL/L SAMPLE ID (B)(6); INITIAL RESULT = 2.47 MMOL/L, REPEAT = 0.82 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045851 ↗
• MalfunctionNov 21, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON AN ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6): INITIAL: 0.43, REPEATED: 0.63, REPEAT ON DIFFERENT ANALYZER: 0.40. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833618 ↗
• MalfunctionSep 25, 2022Low Test Results; Low Test Results

  THE CUSTOMER STATED FALSELY DECREASED MAGNESIUM RESULTS WERE GENERATED ON THE ALINITY C ANALYZER FOR THREE PATIENTS. THE CUSTOMER WAS MADE AWARE OF THE ISSUE WHEN THE PHYSICIAN QUESTIONED THE LOW MAGNESIUM RESULTS. THE FOLLOWING DATA WAS PROVIDED: NORMAL PATIENT RANGE IS 1.6 TO 2.6 MG/DL. PATIENT 4 INITIAL RESULT = 1.24 MG/DL, REPEAT RESULT = 1.66 MG/DL. PATIENT 6 INITIAL RESULT = 1.18 MG/DL, REPEAT RESULT = 1.63 MG/DL. PATIENT 7 INITIAL RESULT = 1.25 MG/DL, REPEAT RESULT = 1.70 MG/DL NO IMPACT TO PATIENT. MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481865 ↗
• MalfunctionAug 24, 2022High Test Results; High Test Results

  HOLD CM THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) INITIAL=2.53 MMOL/L /REPEATED=0.77 MMOL/L .LABORATORY REFERENCE RANGE FOR MAGNESIUM=0.5 TO 1.00 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285583 ↗
• MalfunctionJul 1, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(4). REPEAT TESTING WAS LOWER ON A DIFFERENT ALINITY C PROCESSING MODULE. SID (B)(6): INITIAL RESULT: 0.73 MMOL/L, REPEAT: 0.49 MMOL/L. NORMAL RANGE: 0.66 TO 1.07 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885564 ↗
• MalfunctionApr 29, 2022High Test Results; High Test Results

  THE CUSTOMER QUESTIONED MAGNESIUM RESULTS FOR ONE PATIENT. THE FOLLOWING WAS PROVIDED: SERIAL NUMBER (B)(4) GENERATED RESULT FOR SID (B)(6) INITIAL RESULTS: 0.79 MMOL/L. REPEAT ON SERIAL NUMBER (B)(4): 0.50 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253186 ↗
• MalfunctionApr 6, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR TWO PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.66-1.07 MMOL/L): SAMPLE ID: (B)(6) INITIAL RESULT, ON (B)(6) 2022, WAS 3.26, REPEAT WAS 0.93 MMOL/L. SAMPLE ID: (B)(6) INITIAL RESULT, ON (B)(6) 2022, WAS 2.52, REPEAT WAS 0.89 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022910 ↗
• MalfunctionJan 14, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED MAGNESIUM RESULTS WERE GENERATED ON THE ALINITY C PROCESSING MODULE. ONE EXAMPLE WAS PROVIDED. SAMPLE ID (B)(6) TESTED AT (B)(6) ON (B)(6) 2021. THE CUSTOMER'S CRITICAL RANGE IS BELOW (B)(6). THE SAMPLE WAS TESTED TWO ADDITIONAL TIMES WITH RESULTS OF (B)(6) NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261225 ↗
• MalfunctionJan 9, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE (B)(4) FOR ONE SAMPLE. ON (B)(6) 2021 SID (B)(6) INITIAL RESULT ON (B)(4) (LOT 82496UN21) = 0.66 MMOL/L, REPEAT = 0.51 MMOL/L, REPEATS ON (B)(4) = 0.51 MMOL/L AND 0.50 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13201037 ↗