Alinity 07P9920Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380740135102), received between Dec 26, 2017 and Feb 13, 2024 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “High Test Results” (24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C CREATININE RESULT GENERATED FOR A 21 YEAR OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.70-1.20 MG/DL): (B)(6)2024 INITIAL RESULT = 5.32 MG/DL, (B)(6)2024 REPEAT RESULT = 1.13 MG/DL (B)(6)2024 SAME PATIENT NEW SAMPLE; RESULT ON ANOTHER ANALYZER = 1.01 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698123 ↗
• MalfunctionFeb 6, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CREATININE AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE IS 50-98 UMOL/L. SAMPLE ID (B)(6)INITIAL RESULT WAS 1323.10 UMOL/L. REPEAT RESULT WAS 59.69 UMOL/L. REPEATED RESULT ON ANOTHER ANALYZER ((B)(6)) WAS 58 UMOL/L. THE CUSTOMER REPORTED THAT ALL CONTROL LEVELS FOR CREATININE ARE IN RANGE. 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 18655317 ↗
• MalfunctionJan 29, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) TWO PRIMARY SAMPLE TUBES WERE DRAWN OFF-SITE, THE CUSTOMER PREPARED AN ALIQUOT OF EACH TUBE. ALIQUOT 1 PROCESSED ON (B)(6) 2024 CREATININE = 189 UMOL/L (NORMAL RANGE: 64-110 UMOL/L) NEW SAMPLE TESTED ON (B)(6) 2024 WAS NORMAL. THE CUSTOMER THEN PROCESSED THE ORIGINAL PRIMARY TUBES AND THE 2 ALIQUOTS: PRIMARY TUBE 1 = 90.4 UMOL/L, PRIMARY TUBE 2 = 84.3 UMOL/L, ALIQUOT 1 = 132.4 / 127.2 UMOL/L, ALIQUOT 2 = 77 / 76.4 UMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597080 ↗
• MalfunctionAug 28, 2023High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED ALINITY C CREATININE RESULTS WERE GENERATED. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6): INITIAL RESULT OF 347.0 UMOL/L RETESTED AT 73.2 UMOL/L AFTER RECENTRIFUGATION SID (B)(6): INITIAL RESULT OF 212.2 UMOL/L RETESTED AT 55.7 UMOL/L AFTER RECENTRIFUGATION NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633802 ↗
• InjuryNov 22, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ALINITY C CREATININE RESULT FOR A FEMALE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS TREATED ACUTELY WITH AN UNSPECIFIED TREATMENT. THE FOLLOWING EXAMPLE RESULTS PROVIDED: (B)(6) 2022 SID (B)(6)= 576 UMOL/L. (B)(6) 2022 SID (B)(6)= REPEAT (1:10 DILUTION) 300 UMOL/L, REPEAT ON SECOND ALINITY IN THE LAB 300 UMOL/L EVEN THOUGH IT WAS REQUESTED, NO ADDITIONAL INFORMATION REGARDING THE ACUTE TREATMENT OR PATIENT HARM WAS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 15843702 ↗
• MalfunctionJun 24, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CREATININE RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID (B)(6) INITIAL RESULT = 2.88 MG/DL, (B)(6) 2022 SID (B)(6) INITIAL RESULT = 1.94 MG/DL, REFERENCE LABORATORY RESULT = 1.9 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801368 ↗
• MalfunctionJun 17, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CREATININE RESULTS FOR ONE PATIENT WHO WAS REFERRED TO A SPECIALIST BASED ON THE ELEVATED RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). MEASUREMENT 1: 2.88 MG/DL (B)(6) 2022. MEASUREMENT 2: 1.94 MG/DL (B)(6) 2022 NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735409 ↗
• MalfunctionMay 6, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C CREATININE RESULT FOR ONE SAMPLE THAT WAS REPORTED OUT OF THE LABORATORY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022, SID (B)(6) INITIAL RESULT = 586.8 UMOL/L, REPEATS ON A 2ND ALINITY = 120.8 UMOL/L, 120.1 UMOL/L, AND 113.1 UMOL/L, REPEATS ON A 3RD ALINITY = 119.7 UMOL/L THE PATIENT WAS REFERRED TO A NEPHROLOGIST DUE TO THE DISCREPANT RESULT. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304343 ↗
• MalfunctionApr 14, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A (B)(6) ALINITY C CREATININE RESULT OF (B)(6) WAS GENERATED FOR A PATIENT SAMPLE ((B)(6)) ON (B)(6), 2022 THAT RETESTED AT (B)(6). AN ADDITIONAL OCCURRENCE OCCURRED ON (B)(6), 2022. SID (B)(6) INITIAL RESULT WAS (B)(6) AND REPEAT RESULT WAS (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14114113 ↗
• MalfunctionJan 19, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CREATININE RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID IDM (B)(6) INITIAL RESULT WAS 1106.94 UMOL/L, REPEATED 98.30 UMOL/L, REPEATED ON ANOTHER ANALYZER 93 UMOL/L, SID IDM (B)(6) INITIAL RESULT 1222.26 UMOL/L, REPEATED 105 UMOL/L, (REFERENCE RANGES FOR SERUM CREATININE: MEN 63.6-110.5 UMOL/L; WOMEN 50.4-98.1 UMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13291579 ↗
• MalfunctionAug 20, 2021High Test Results; High Test Results

  THE CUSTOMER IDENTIFIED FALSELY ELEVATED ALINITY C CREATININE RESULTS FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2021 INITIAL RESULT 8 MG / DL, REPEATED 0.52 MG EACH / DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348328 ↗
• MalfunctionJul 30, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULT ON ONE PATIENT GENERATED ON THE ALINITY C PROCESSING MODULE. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL = 375.6UMOL/L (NORMAL RANGE FOR FEMALE 50-98UMOLL) / RETESTED = 64UMOL/L / THE SAMPLE WAS THEN TESTED ON ALL 3 ANALYZERS WITH RESULTS 66, 67, 71UMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253982 ↗
• MalfunctionDec 23, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A (B)(6) ALINITY C CREATININE RESULT ON ONE MALE PATIENT. THE RESULTS PROVIDED WERE ON (B)(6) 2020 INITIAL = 400UMOL/L (NORMAL IS 110) / RETEST THE NEXT DAY ON A NEW SAMPLE, SAME PATIENT = 73UMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11065926 ↗
• MalfunctionOct 9, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ALINITY C CREATININE OF 2.7 MG/DL ON SID (B)(6) THAT REPEATED 0.66 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ALINITY ANALYZER WITH NORMAL RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10659282 ↗
• MalfunctionOct 8, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ALINITY C CREATININE RESULTS FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: . ON (B)(6) 2020, SID: (B)(6) = CREATININE = 2.39 MG/DL, REPEAT = 2.43 MG/DL. ON (B)(6) 2020, CUSTOMER RETESTED SAME PATIENT SAMPLE, AND GENERATED A CREATININE RESULT OF 1.39 MG/DL. ON (B)(6) 2020, SID (B)(6) = CREATININE = 1.42 MG/DL (ON A DIFFERENT ALINITY C ANALYZER), REPEAT CREATININE = 1.71 MG/DL (AFTER RE-CALIBRATING ON ORIGINAL ALINITY C ANALYZER). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10650093 ↗
• MalfunctionSep 10, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CREATININE RESULTS ON TWO PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 (B)(6) INITIAL = 6.62MG/DL / RETEST = 6.78 / AFTER PHYSICIAN QUESTIONED RETEST = 2.63 / NEW SAMPLE, SAME PATIENT = 1.0 / PLASMA SAMPLE FROM (B)(6) 2020 = 0.91MG/DL; (B)(6) INITIAL = 5.98 / RETEST = 4.42MG/DL / AFTER PHYSICIAN QUESTIONED = 4.01, 3.99MG/DL / NEW SAMPLE, SAME PATIENT =0.82MG/DL(NORMAL RANGE MALE= 0.7 - 1.2, FEMALE= 0.5 - 0.9MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10514124 ↗
• MalfunctionJun 26, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE ON ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS WERE PROVIDED: ON (B)(6) 2020 SID (B)(6) CREATININE=177 UMOL/L ON (B)(6) 2020 REPEATED ON ANOTHER ALINITY =98 UMOL/L(% DIFFERENCE=81%) (LABORATORY REFERENCE RANGE FOR MEN=63.6 TO 110.5 UMOL/L AND WOMEN=50.4 TO 98.1 UMOL/L).THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10203144 ↗
• MalfunctionFeb 21, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CREATININE RESULT WHEN PROCESSING ON THE ALINITY C. THE INITIAL RESULT WAS 17.75 MG/DL AND RETEST WAS 0.77 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9739782 ↗
• MalfunctionJan 28, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING ALINITY C CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. SID (B)(6) INITIAL 2.67 MG/DL. REPEAT (NO SID PROVIDED) 0.75, 0.71 MG/DL. REPEAT USING A NEW SAMPLE. (SID (B)(6)) 0.73 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9639133 ↗
• MalfunctionDec 26, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: SID 500010630 = 2.934 / 1.99 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520943 ↗
• MalfunctionDec 3, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY INCREASED CREATININE RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: 10.86 / 0.86 MG/DL. CREATININE HISTORICALLY = 0.81 / 0.83 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9404450 ↗
• MalfunctionJun 12, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS ON ONE PATIENT GENERATED ON THE ALINITY C ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2019:SID (B)(6) INITIAL = 1.04MG/DL / REPEATED ON SID (B)(6) ON (B)(6) 2019 = 2.00 / REPEATED ON (B)(6) 2019 = 1.35MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691838 ↗
• MalfunctionDec 3, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING ALINITY C CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. SID (B)(6) INITIAL 2.67 MG/DL. REPEAT (NO SID PROVIDED) 0.75, 0.71 MG/DL. REPEAT USING A NEW SAMPLE ((B)(6)) 0.73 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126514 ↗
• MalfunctionDec 26, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTS THAT ONE PATIENT SAMPLE (SID (B)(6)) GENERATED AN INITIAL ALINITY CREATININE ASSAY RESULT OF 3.37 MG/DL ON AN ALINITY C PROCESSING MODULE. THE SAMPLE RETESTED AT 0.69 MG/DL. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7146078 ↗