Alinity 07P9930Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740135119), received between Sep 19, 2019 and Jun 2, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C CREATININE RESULT GENERATED FOR A FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT = 23.34 MG/DL, REPEAT = 0.94 MG/DL, 0.95 MG/DL, 0.95 MG/DL, 0.97 MG/DL, REPEAT RESULTS ON ANOTHER ANALYZER (B)(6) = 0.88 MG/DL AND 0.86 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051211 ↗
• MalfunctionApr 24, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS ON ALINITY C PROCESSING MODULE FOR TWO PATIENTS. THE RESULTS PROVIDED WERE: 22MAR2023 SID (B)(6) INITIAL=10.59 MG/DL /REPEATED=0.67 MG/DL AND 0.65 MG/DL TWO SPECIMENS FROM SAME PATIENT SID (B)(6) ENDING WITH -52 AND -01. THOSE RESULTS ARE AS BELOW. 03APR2023 SID (B)(6) =>37.00 MG/DL /REPEATED=42.53 MG/DL /SAME PATIENT DIFFERENT TUBE SID (B)(6) =0.84 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796378 ↗
• MalfunctionFeb 22, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY C CREATININE RESULT FOR A PATIENT THAT THE PHYSICIAN WAS QUESTIONING AFTER RECEIVING THE RESULT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR CREATININE: 0 -1.3 MG/DL). ON (B)(6) 2023 SID (B)(6): CREATININE RESULT: 0.5 MG/DL ON (B)(6) 2023 SID (B)(6): CREATININE RESULT: 3.039 / SID (B)(6): CREATININE RESULT: 4.38 MG/DL I-STAT CREATININE RESULT: 6.2 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421956 ↗
• MalfunctionJun 23, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT DISCREPANT ALINITY C CREATININE RESULTS WERE GENERATED FOR A PATIENT SAMPLE. SID (B)(6). INITIAL RESULT: 549.5418 UMOL/L, REPEAT RESULT: 64.0599 UMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14792568 ↗
• MalfunctionFeb 21, 2022High Test Results; High Test Results

  THE ACCOUNT STATED A FALSE ELEVATED ALINITY C CREATININE RESULT WAS GENERATED ON A PATIENT SAMPLE THAT REPEATED LOWER. THE PATIENT SERUM SAMPLE TESTED ALINITY C CREATININE OF 14.5 MG/DL WHICH WAS QUESTIONED AS TOO HIGH BY A PHYSICIAN. THE SAMPLE REPEATED SLIGHTLY LOWER THAN 1 MG/DL. NO SPECIFIC PATIENT INFORMATION WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573575 ↗
• MalfunctionNov 23, 2021High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ALINITY C CREATININE RESULT OF 539 UMOL/L WAS GENERATED FOR A PATIENT SAMPLE (ID (B)(6)) ON (B)(6) 2021. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SUSPECTED ACUTE KIDNEY INJURY (AKI) APPROXIMATELY 2 HOURS LATER BASED ON THE RESULT. A NEW SAMPLE WAS DRAWN (ID (B)(6)) AND THE RESULT WAS 78 UMOL/L. THE FIRST SAMPLE WAS THEN RETESTED AND THE RESULT WAS 83 UMOL/L. THERE IS NO REPORT OF ANY INCORRECT/UNNECESSARY TREATMENT GIVEN TO THE PATIENT OR ANY PATIENT INJURY BASED ON THE FALSELY ELEVATED RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863984 ↗
• MalfunctionApr 14, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ALINITY C CREATININE RESULT. SAMPLE ID(B)(6) GENERATED AN INITIAL RESULT OF 660.87 UMOL/L AND RETEST OF 82.30 UMOL/L. DUE TO THE ELEVATED RESULT THE PATIENT WENT TO THE A&E AND HAD BLOOD TESTS. NO FURTHER IMPACT WAS REPORTED. DUE TO THE ELEVATED RESULT THE PATIENT WENT TO THE A&E AND HAD BLOOD TESTS. NO FURTHER IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666939 ↗
• MalfunctionJan 29, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CREATININE RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 (B)(6) INITIAL = 9.35MG/DL (NORMAL RANGE 0.72-1.25MG/DL) / RETEST AFTER 30 MINUTES = 0.73MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11250469 ↗
• MalfunctionJun 22, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2020, SID (B)(6) = 428 UMOL/L, REPEATED ON ANOTHER ALINITY C ON (B)(6) 2020 = 83 UMOL/L. REFERENCE RANGE: MALE (63.6 - 110.5 UMOL / L) FEMALE (50.4 - 98.1 UMOL / L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181512 ↗
• MalfunctionMar 2, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ALINITY C CREATININE OF 462 UMOL/L ON A PATIENT SAMPLE ID (B)(6) THAT REPEATED 65 UMOL/L ON ANOTHER ANALYZER. HISTORICAL CREATININE PATIENT VALUES RANGED 60 TO 84 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. PATIENT ETHNICITY AND RACE WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9776631 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ALINITY C CREATININE RESULT FOR A MALE CANCER PATIENT. SAMPLE ID (B)(6) GENERATED 4.28 MG/DL AND REPEAT THE NEXT DAY UNDER SID (B)(6) GENERATED 1.11 MG/DL. THE CUSTOMER FURTHER INDICATED THE SUBSEQUENT SAMPLE FROM THE PATIENT ALSO GENERATED 1.1 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9757365 ↗
• MalfunctionJan 2, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CREATININE RESULTS ON THREE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6) = 2.52MG/DL / 0.93MG/DL; SID (B)(6) = 2.52MG/DL / REPEATED = 0.91MG/DL; SID (B)(6) = 20.6MG/DL / REPEATED = 86.6MG/ DL (NORMAL RANGE 0.20 TO 37.00MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9539771 ↗
• MalfunctionNov 26, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS ON THE ALINITY ANALYZER. THE FOLLOWING DATA WAS PROVIDED (UMOL/L): SID (B)(6) INITIAL 184.7, REPEAT 150, SID (B)(6) INITIAL 201.1, REPEAT 106. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9377861 ↗
• MalfunctionSep 19, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS ON TWO PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 SID (B)(6) CREAT = 13.98MG/DL / ON (B)(6) 2019 NEW DRAW (SID (B)(6)) IN ER = 0.69MG/DL; ON A SECOND ANALYZER SERIAL NUMBER (B)(4). THE (B)(6) 2019 SAMPLE = 12.66MG/DL; ON (B)(6) 2019 SID (B)(6) = 8.6MG/DL / 0.96MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088432 ↗
• MalfunctionSep 19, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON 20AUG2019 SID (B)(4) CREAT = 13.98MG/DL / ON 21AUG2019 NEW DRAW (SID (B)(4)) IN ER = 0.69MG/DL; ON A SECOND ANALYZER SERIAL NUMBER (B)(4) THE 20AUG2019 SAMPLE = 12.66MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088411 ↗