AlinIQ 03R89-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380740158255), received between Jun 20, 2019 and Apr 15, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2025Installation-Related Problem; Installation-Related Problem

  THE CUSTOMER OBSERVED A CONFIGURATION ERROR AFTER ADDING A NEW ANALYZER ON THE ALINIQ AMS. THE CUSTOMER REPORTED THAT THERE WAS A CONFIGURATION ERROR WHEN THE CS COAGULATION ANALYZER WAS ADDED TO THE AMS TO REPLACE THE ACL TOP COAGULATION ANALYZER. THE RESULTS FROM THE CS ANALYZER WERE SENT TO THE LIS INDICATING THEY WERE GENERATED ON THE ACL TOP AND, THEREFORE, A MISMATCH IN THE REFERENCE RANGES OCCURRED DUE TO THE DIFFERENCE IN PLATFORMS. THERE WERE NUMEROUS SAMPLES AFFECTED BY THIS SINCE (B)(6) 2025. THE CUSTOMER INDICATED THERE WAS NO DELAYED OR MISSED TREATMENT AND NO PHYSICIANS CONTACTED THE LABORATORY WITH CONCERNS ABOUT THE RESULTS REPORTED OUT. THE CUSTOMER NOTICED THE ISSUE IN THE LIS, CORRECTED IT MANUALLY IN THE LIS, AND NOTIFIED PHYSICIANS OF THE ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21844378 ↗
• MalfunctionFeb 8, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT AFTER A NEW RULE WAS IMPLEMENTED IN THE ALINIQ AMS, THAT RESULTS GENERATED FOR URINARY PROTEINS AND GLYCOSURIA WERE INCORRECT. THE NEW RULE WAS TO HAVE A CONVERSION FACTOR FOR THE RESULTS TO MATCH A CHANGE IN THE UNIT OF MEASURE FROM MG/DL TO G/L FOR. THE CUSTOMER FURTHER ELABORATED THAT THE INCORRECT RESULTS WERE BECAUSE THE CONVERSION FACTOR DID NOT OCCUR. THE CUSTOMER REPORTED THAT THEY CORRECTED THE INCORRECT RESULTS THAT WERE GENERATED ON (B)(6) 2023, WHICH IMPACTED 37 PATIENTS. UPON FURTHER REVIEW, THE RULE PLACED IN ALINIQ AMS TO CONVERT THE UNIT OF MEASURE FROM MG/DL TO G/L WAS PLACED AFTER AN ESTABLISHED RULE. THIS ESTABLISHED RULE TAKES THE RESULTS FROM THE ALINITY ANALYZER AND PLACES THEM INTO THE CUSTOMER¿S LABORATORY INFORMATION SYSTEM (LIS). SINCE THIS ESTABLISHED RULE WAS POSITIONED BEFORE THE NEW CONVERSION RULE, THE ESTABLISHED RULE WAS TRIGGERED FIRST. THEREFORE, THE CONVERSION FACTOR DID NOT OCCUR BEFORE THE RESULTS ENTERED THE CUSTOMER¿S LIS. THE SEQUENCE OF THE RULES HAS BEEN CHANGED SO THAT THE CONVERSION RULE OCCURS FIRST. THE CUSTOMER CONFIRMED THAT THE RESULTS NOW HAVE THE CORRECT VALUE AND UNIT OF MEASURE. THERE WAS NO REPORTED I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669281 ↗
• MalfunctionOct 27, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED ERRORS IN THE ALINIQ AMS SOFTWARE CAUSING INCORRECT C3 AND C4 COMPLEMENT RESULTS TO BE GENERATED. CUSTOMER STATES THERE WAS A TYPO ON THE UPLOAD CODE FROM A3600 AUTOMATION SYSTEM TO AMS AND LIS. THE ERRORS WERE AS FOLLOWS: AMS - THE C3 UPLOAD CODE FROM A3600 WAS INCORRECTLY SET AS C4, HOWEVER FIXED IMMEDIATELY. THE C3 AND C4 COMPLEMENTS HAD CORRECT RESULTS ON THE ALINITY AS FOLLOWS: SAMPLE ID (B)(6) = 103.4 AND C4 = 18.2 ON THE AMS THE CORRECT VALUES APPEARED FOR C3, BUT NO VALUE APPEARED ON C4. LIS - ON RECEIVING C3 RESULTS, THEY WERE BEING REPLICATED ALSO AS C4. C3 AND C4 HAD THE SAME VALUE AS C3. ONCE THE TYPO WAS FIXED, SERVICES WERE RESTARTED, RESULTS WERE RESENT. THE CUSTOMER ERASED RESULTS ON THE LIS, WHICH CAUSED TESTS TO BE REPEATED; HOWEVER, THIS TIME, RESULTS WERE FINE. THE FOLLOWING IS A LIST OF PATIENT ID¿S AND THE REQUEST ID THAT POTENTIALLY WERE AFFECTED. NOT ALL ID¿S HAD BAD RESULTS IN AMS, BUT THEY DID HAVE BAD RESULTS IN LIS, DUE TO A MISCONFIGURATION: PATIENT ID (B)(6), REQUEST ID IN AMS 10262981 PATIENT ID (B)(6), REQUEST ID IN AMS 10266350 PATIENT ID (B)(6), REQUEST ID IN AMS 11401828 PATIENT ID (B)(6), REQUEST ID IN AMS 11401841 PATIENT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020985 ↗
• MalfunctionApr 20, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT FOR SAMPLE ID (B)(6), PROCESSED ON (B)(6) 2023, A POS (POSITIVE) COV15 (COVID) TEST RESULT WAS ERRONEOUSLY RELEASED AS NEG (NEGATIVE). THE ALINIQ AMS ANALYZER MANAGEMENT SYSTEM) RELEASED A NEG (NEGATIVE) RESULT THROUGH A CALCULATION DONE BY AN AMS RULE BASED ON AN ASSESSMENT OF THE THREE NUMERIC RESULTS FOR COV15 GENE E, COV15B ORF AB AND COV15C QC. THE FINAL RESULT FOR THE TEST WAS MANUALLY VALIDATED BY THE USER, RELEASED TO THE LIS AND SENT TO THE COMPETENT DEPARTMENT. AS AGREED, THE AMS RULE, IMPLEMENTED DURING THE INSTALLATION ACTIVITY AT THE CUSTOMER'S PREMISES, ONLY EVALUATED THE QUANTITATIVE RESULTS RECEIVED BY THE INSTRUMENT, NOT CONSIDERING QUALITATIVE AND INVALID ONES. IN THIS SPECIFIC CASE, THE SAMPLE REPORTED, GENE E, IS THE NUMERIC RESULT OF THE COV15A GENE E TEST (0.00), ORF IS THE NUMERIC RESULT OF THE COV15B ORF AB TEST (0.00) WHILE QC IS THE NUMERIC RESULT OF THE COV15C QC TEST (33.82). THE RULE WAS TRIGGERED, RELEASING THE QUALITATIVE RESULT (NEG). THE AMS RELEASED AN "INVALID" RESULT SIGNALED VIA THE "X" FIELD IN THE DRIVER AND RELATED TO THE QUALITATIVE RESULT. THE "INVALID" INFORMATION WAS NOT SENT BY THE INSTRUMENT ON THE QUANTITATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777685 ↗
• MalfunctionFeb 23, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED INCORRECT RESULTS WERE BEING REPORTED BY THE ALINIQ AMS BASE SOFTWARE. THE ALINIQ AMS REPORTED THE RESULTS FROM THE GENEXPERT AS NEGATIVE AND NOT DETECTED INSTEAD OF FAIL. WHEN THE GENEXPERT ANALYZER IS UNABLE TO PRODUCE A DEFINITIVE POSITIVE OR NEGATIVE RESULT, IT GENERATED AN ERROR AS ¿ERROR¿ AND THE RULE IN THE AMS SHOULD HAVE RESULTED THE TEST AS ¿FAIL¿ IF ¿ERROR¿ IS PRESENT. IT WAS NOTED THAT THERE WERE MULTIPLE RULES SETUP FOR THE SAME TEST AND THE INITIAL RESULT WAS SET TO ¿FAIL¿, HOWEVER, SUBSEQUENT RULES CHANGED ITS VALUE AND THE FINAL RESULT WAS SET AT NDE (NOT DETECTED). THE CUSTOMER CAUGHT THE ISSUE RIGHT AWAY AND THE CLINICIANS WERE NOTIFIED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427077 ↗
• MalfunctionOct 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT FERRITIN RESULTS REPORTED ON ALINIQ AMS SOFTWARE FOR SEVERAL PATIENTS. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) CONFIGURED WRONG ASSAY CODE 1460 FOR FERRITIN ASSAY BY THE MISTAKE, HOWEVER LATER, THE FSR CORRECTED THE FERRITIN ASSAY CODE 61 CONFIGURATION. THE CUSTOMER SENT OUT CORRECTED FERRITIN RESULTS TO PATIENTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562909 ↗
• MalfunctionApr 27, 2022Application Security Problem; Application Security Problem

  THE CUSTOMER REPORTED THEY WERE ALERTED WITH AN ERROR OF ACCOUNT BLOCKED IN THE DATABASE. AFTER ANALYSIS, IT WAS FOUND THAT THERE WERE 10 ATTEMPTS TO LOG INTO THE ALINIQ AMS DATABASE. THE NEXT DAY THERE WAS ANOTHER BLOCK ON THE ORACLE USER AGAIN; AN UNBLOCK WAS PERFORMED, DAIN WAS MANUALLY EXECUTED AND THE DATABASE WAS BACKED UP. THE RUNNING OF AXEDA (ABBOTTLINK) ON THE SERVER WAS IDENTIFIED, EVEN THOUGH IT WAS NOT CONNECTED DUE TO A LACK OF A VALID CERTIFICATE. ABBOTTLINK WAS DISABLED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219323 ↗
• MalfunctionMar 10, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED B12 RESULTS WERE RELEASED TO THE PHYSICIAN FOR ONE (B)(6) PATIENT. THE PHYSICIAN THEN CHANGED THE B12 DOSAGE BASED ON THE DEPRESSED RESULT. THERE WAS NO REPORTED ADVERSE IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER WILL NOT PROVIDE ANY FURTHER INFORMATION. THE CUSTOMER ALSO REPORTED THAT RESULTS WERE GENERATED CORRECTLY ON THE ALINITY I ANALYZER, BUT INTERPRETED INCORRECTLY BY THE AMS, AS THE RULE WAS SET UP WRONG BY ABBOTT. THE FLAGS (< AND >) WERE INTERPRETED AS LESS THAN THE LINEARITY FOR EACH ASSAY AND WERE THEN SENT TO THE LIS. THE LAB TECHNICIANS THEN MANUALLY REVIEWED THE RESULTS AND RELEASED THEM TO THE PHYSICIANS. THE CUSTOMER STATED THAT 4 PATIENTS WERE POTENTIALLY IMPACTED BY THESE INCORRECT RESULTS, BUT INFORMATION WAS ONLY PROVIDED FOR THE ONE B12 PATIENT ABOVE. THE CUSTOMER ALSO REPORTED FALSELY DEPRESSED CMV, TOXO-G, TSH, ANTI-TPO, ANTI-THYROGLOBULIN, B12, ANTI-CCP, FOLATE, (B)(6), PROGESTERONE, AND VITAMIN D RESULTS. THE RESULTS PROVIDED WERE: (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9812613 ↗
• InjuryAug 15, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ONE PATIENTS RESULTS WERE INCORRECTLY ASSIGNED TO ANOTHER PATIENT BY THE AMS SOFTWARE AND REPORTED OUT OF THE LABORATORY. BOTH PATIENTS SHARED THE SAME SID (B)(4). RESULTS PROVIDED: ELEVATED CALCIUM (10.7 MG/DL) AND PTH (229.1 PG/ML) RESULTS FROM A (B)(6) MALE PATIENT TESTED ON (B)(6) 2019 WERE REPORTED ON A (B)(6) FEMALE PATIENT ON (B)(6) 2019 DUE TO THE SAME SID IN USE BY THE CUSTOMER. DUE TO THE INCORRECT RESULTS REPORTED, THE FEMALE PATIENT FROM (B)(6) 2019 HAD AN ALLERGIC REACTION TO A RADIOACTIVE ISOTOPE ADMINISTERED DURING A BONE SCAN. NO FURTHER INFORMATION REGARDING THE ALLERGIC REACTION WAS PROVIDED. A MEDICAL OPINION WAS OBTAINED, AND A SERIOUS INJURY CANNOT BE RULED OUT BASED ON THE INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8898491 ↗
• InjuryJun 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED AN FALSELY ELEVATED POTASSIUM RESULT (6.3) ON THE ALINIQ AMS SOFTWARE. THE FEMALE PATIENT SID (B)(6) (BORN (B)(6)) RECEIVED AN UNNECESSARY ADMINISTRATION OF THE FOLLOWING: 10 UNITS ACTRAPID INSULIN AND 50ML 50% DEXTROSE IV, 100ML 10% CALCIUM GLUCONATE IV. THE CUSTOMER STATES THE PATIENT WAS SINCE DISCHARGED AND A LONG-TERM NEGATIVE IMPACT IS NOT ANTICIPATED.

  Patient problems: No Code Available

  MAUDE report 8718254 ↗