Alinity 03R6701Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,197 adverse event reports that list this exact device (DI 00380740137380), received between Jan 19, 2018 and Sep 29, 2026 — classified as 1 death, 22 injuries, 1,174 malfunctions.

The most frequently reported specific device problem is “High Test Results” (611 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0681-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,197 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results

  The customer reported a falsely elevated Alinity c Magnesium (Mg) result generated on the Alinity c Processing Module. The following data was provided:SID 7862520115:Initial Magnesium result = 8.9 mg/dLRepeat Magnesium result = 1.8 mg/dL (Reference range: 1.6-2.6 mg/dL)QC values for Magnesium were within range. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931443 ↗
• MalfunctionSep 25, 2026Low Test Results

  The customer observed a falsely decreased Alinity c Carbon Dioxide result for one patient. The following data was provided (Customer¿s reference range is 19-29 mmol/L):Sample ID (b)(6) initial result, on (b)(6) 2026, was 18, repeat result on a different analyzer was 22 mmol/L. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899273 ↗
• MalfunctionSep 23, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872184 ↗
• MalfunctionSep 23, 2026Low Test Results

  The customer observed falsely depressed Alinity c Sodium results for one 66-year-old male patient on the Alinity serial number (b)(6). The sample was repeated with higher results. The following data was provided:SID: (b)(6) processed on (b)(6) 2026.Initial result processed on Alinity c serial number, (b)(6), Sodium = 118 Repeat processed on (b)(6) and (b)(6) = 141 and 142 mmol/L.Sodium Reference Range: 136-145 mmol/L No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871826 ↗
• MalfunctionSep 23, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869449 ↗
• MalfunctionSep 22, 2026High Test Results

  The customer observed falsely elevated Magnesium results generated from Alinity c processing module for a 74yrs old male patient. The results provided were: On (b)(6) 2026: SID (b)(6): Initial=6.71 mg/dL /repeated=1.89 mg/dL. Repeated on Alinity (b)(6)=1.94 mg/dL. Customer reference range for Magnesium=2.09 to 2.84 mg/dL. There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856020 ↗
• MalfunctionSep 17, 2026High Test Results

  The customer observed falsely elevated Magnesium results on the Alinity c Processing Module, serial number (b)(6). The following example data was provided:SID (b)(6) initial result = 6.6 repeat result = 2.0 mg/dL.Customer Reference Range = 1.6-2.6 mg/dL No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801000 ↗
• MalfunctionSep 15, 2026High Test Results

  The customer reported elevated Magnesium generated from Alinity c Processing Module (SN: (b)(6)) and provided the following data for a 51 year old female patient:On (b)(6)2026, Sample ID (b)(4) magnesium result was 6.2 mg/dL. Sample was retested on the analyzer and got a result of 1.9 mg/dL. Sample was also tested twice on another Alinity c Processing Module (SN: (b)(6)) and results were 1.8 mg/dL and 1.9mg/dL.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 50777717 ↗
• MalfunctionSep 11, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735108 ↗
• MalfunctionSep 9, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702099 ↗
• MalfunctionAug 25, 2026High Test Results

  The customer observed falsely elevated Magnesium results generated from Alinity c processing module for a 84yrs old male patient. The result provided were: On (b)(6) 2026: SID: (b)(6): Initial=6.8 mg/dL /repeated=1.9 mg/dL. Customer reference range for Magnesium=1.8 to 2.6 mg/dL.There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50431059 ↗
• MalfunctionAug 24, 2026Low Test Results

  The customer observed depressed Sodium when processing on Alinity c Processing Module. SID (b)(6)(male 81 years old) generated Sodium of 118 mmol/L that repeated 141 mmol/L. The repeated result matched patient historical result and was reported out of lab. The customer normal range: Sodium 135-145 mmol/L. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408415 ↗
• MalfunctionAug 20, 2026Low Test Results

  The customer observed depressed Sodium when processing on Alinity c Processing Module. On (b)(6) 2026, SID (b)(6) generated Sodium of 102 mmol/L. The result was reported out of lab and patient was referred to intensive care unit. No treatment was given. On (b)(6) 2026, the same patient generated Sodium of 140 mmol/L, matching historical patient Sodium of 140 mmol/L. The customer normal Sodium range is >125 mmol/L. No impact on patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356479 ↗
• MalfunctionJul 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063471 ↗
• MalfunctionJul 17, 2026Thermal Decomposition of Device

  DURING STARTUP FOLLOWING THE INSTALLATION OF AN ALINITY C PROCESSING MODULE, INSTRUMENT ERROR 5016-C319 (WASH SOLUTION PUMP) WAS GENERATED. THE ANALYZER WAS ASSESSED, AND BURN MARKS WERE OBSERVED ON AN INTERNAL BOARD AND THE ASSOCIATED CABLES CONNECTED TO THE BOARD. NO SMOKE OR BURNING ODOR WERE OBSERVED. THERE WAS NO REPORTED IMPACT TO USER SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854317 ↗
• MalfunctionJul 9, 2026High Test Results

  THE CUSTOMER OBSERVED ELEVATED SODIUM WHEN PROCESSING ON ALINITY C PROCESSING MODULE. THE CUSTOMER OBSERVED ELEVATED SODIUM RESULTS FOR SAMPLES THAT WERE REPEATED USING SPARE SAMPLES FOR THE SAME PATIENT GENERATING NORMAL RESULTS OF 137-141 MMOL/L. ON (B)(6) 2026, ID (B)(6) (72-YEAR-OLD FEMALE) GENERATED SODIUM OF 162, 161 MMOL/L THAT REPEATED WITH DIFFERENT SPARE SAMPLE OF 137 MMOL/L ON THE SAME ALINITY C PROCESSING MODULE. THE SAME SAMPLE, SID (B)(6), WAS ALSO TESTED ON ANOTHER INSTRUMENT WITH SODIUM OF 162 MMOL/L FOR TROUBLESHOOTING. NO ABNORMAL RESULTS WERE REPORTED TO CLINICIANS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25772931 ↗
• MalfunctionJul 7, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PATIENT RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR SEVERAL PATIENTS. THE ONE RESULTS EXAMPLE PROVIDED WERE: SID (B)(6): INITIAL POTASSIUM=8.8 MMOL/L /REPEATED ON ALINITY (B)(6) =3.8 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735134 ↗
• MalfunctionJun 19, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 136 TO 145 MMOL/L (MEQ/L)): INITIAL SODIUM RESULT= 181 MEQ/L; REPEAT RESULT ON THE GAS METER= 138 MEQ/L, SAMPLE WAS REPEATED WITH RESULTS= 151 MEQ/L AND 139 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561784 ↗
• MalfunctionJun 18, 2026High Test Results

  THE FOLLOWING INCIDENT DESCRIBES A USE ERROR. THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2026, SAMPLE ID (B)(6) (MALE, 60 YEARS OLD) FIRST VALUE > 3.9MMOL/L, RETEST RESULT WAS 0.67 MMOL/L. RESUTLS GENERATED FROM SN: (B)(6). THE MEASURING INTERVAL OF THE MAGNESIUM ASSAY IS 0.25 MMOL/L TO 3.90 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25544669 ↗
• MalfunctionJun 12, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 ON THE ALINITY C PROCESSING MODULE FOR A 79-YEAR-OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE, MALE 58 -110 UMOL/L, FEMALE 46 - 92 UMOL/L): (B)(6) 2026, SID (B)(6), INITIAL CREATININE RESULT= 292 UMOL/L; REPEAT RESULTS (ANALYZER (B)(6)) = 96.4 UMOL/L AND 99.3 UMOL/L. HISTORICALLY THE PATIENT HAS RESULTS AROUND 90 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485255 ↗
• MalfunctionJun 5, 2026High Test Results

  THE CUSTOMER REPORTED IMPRECISE RESULTS FOR MULTIPLE ASSAYS (CREATININE, BUN, A-AST, A-ALT, ALKALINE PHOSPHATASE, AND TOTAL BILIRUBIN) FOR MULTIPLE PATIENTS GENERATED ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER STATED THE RESULTS WERE QUESTIONED BY A NURSE. THE CUSTOMER PROVIDED CREATININE RESULTS FOR ONE PATIENT: TESTED ON (B)(6) 2026 AT 10:20 AM: SID (B)(6) (69-YEAR-OLD, MALE): CREATININE RESULT = 2.84 MG/L SID (B)(6) (PATIENT WAS REDRAWN AT 11:35 AM): CREATININE = 0.88 MG/DL. BOTH THESE SAMPLES WERE RUN ON BOTH CUSTOMER ANALYZERS MULTIPLE TIMES. THE RESULTS GENERATED CORRELATED TO THE RESULTS LABELED WITH SID (B)(6). CREATININE REFERENCE RANGE: 0.5-1.5 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408050 ↗
• MalfunctionMay 21, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY C CALCIUM RESULT FOR A 65 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED NORMAL RANGE IS 8.3 TO 10.3 MG/DL): INITIAL RESULT = 21.1 MG/DL, REPEAT ON ANOTHER ALINITY = 9.4 MG/DL HISTORICAL RESULT = 8.6 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243497 ↗
• MalfunctionMay 21, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR A 56 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 117 MMOL/L, REPEAT = 142 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243322 ↗
• MalfunctionMay 18, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ALINITY C PROCESSING MODULE FOR SEVERAL PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 SID (B)(6), INITIAL=3.68 MMOL/L /REPEATED ON ALINITY (B)(6) =0.80 MMOL/L SID (B)(6), INITIAL=3.10 MMOL/L /REPEATED ON ALINITY (B)(6) =0.88 MMOL/L SID (B)(6), INITIAL=2.47 MMOL/L /REPEATED ON ALINITY (B)(6) =0.80 MMOL/L SID (B)(6), INITIAL=2.92 MMOL/L /REPEATED ON ALINITY (B)(6) =0.92 MMOL/L SID (B)(6), INITIAL=2.60 MMOL/L /REPEATED ON ALINITY (B)(6) =0.76 MMOL/L SID (B)(6), INITIAL=3.03 MMOL/L /REPEATED ON ALINITY (B)(6) =0.75 MMOL/L ON (B)(6), 2026 SID (B)(6), INITIAL=2.60 MMOL/L /REPEATED ON ALINITY (B)(6)=0.91 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25205040 ↗
• MalfunctionMay 14, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED ON AN ALINITY C PROCESSING MODULE FOR THREE SAMPLES, HOWEVER ONLY PROVIDED TWO OF THE PATIENT RESULTS. THE FOLLOWING DATA WAS PROVIDED (NORMAL REFERENCE RANGE 136-145 MMOL/L): SID: (B)(6) INITIAL RESULT = 169 MMOL/L, RERUN ON OTHER INSTRUMENT = 142 MMOL/L. SID (B)(6) INITIAL RESULT = 177 MMOL/L, RERUN ON OTHER INSTRUMENT = 143 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173884 ↗