AlinIQ 03R8963Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380740202736), received between Aug 23, 2023 and Mar 4, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Computer Software Problem

  THE CUSTOMER REPORTED THE ALINIQ AMS ASSIGNED TWO PATIENT NAMES TO THE SAME ID (B)(6) WHICH SHOWS UP ON ONE THIRD PARTY ANALYZER WHEN VIEWING PATIENT DATA. THERE WERE NO INCORRECT RESULTS ASSIGNED TO A PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506271 ↗
• MalfunctionFeb 27, 2026Computer Software Problem

  THE CUSTOMER REPORTED THE ALINIQ AMS IS CALCULATING THE INCORRECT ABSOLUTE DIFFERENTIAL VALUES COMING FROM THE CELLAVISION WHEN NRBCS ARE IDENTIFIED. THE CONFIGURATION RULE IS TO USE THE WBCC (CORRECTED WBC) VALUE AND INSTEAD IT IS USING THE WBC-CV VALUE. ALINIQ AMS CONFIRMS THE WBCC WAS CORRECTED USING THE NRBC BUT AMS DID NOT USE THIS RESULT. THE CUSTOMER INDICATED THIS MAY HAVE IMPACTED SAMPLES GOING BACK TO (B)(6) 2022. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: SID (B)(6): LYCV = 37.6 % WBC_CV = 36 WBCC = 3.2 REPORTED ABSOLUTE LYCV = 13.5 (37.6/100X36) THIS SHOULD HAVE USED WBCC: LYCV = 1.2 (37.6/100X3.2). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471367 ↗
• MalfunctionDec 22, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED A FALSELY DECREASED HEMOGLOBIN RESULT RECEIVED IN THE ALINIQ AMS BASE SOFTWARE FOR ONE PATIENT SAMPLE. THE FOLLOWING EVENTS OCCURRED FOR SAMPLE ID (B)(6). ORIGINAL HEMOGLOBIN RESULT WAS RECEIVED IN ALINIQ AMS BASE SOFTWARE AS 65.1 G/L (6.51 G/DL) AND THE FIRST RERUN RESULTS FOR HEMOGLOBIN WAS 149 WHICH DISPLAYED IN AMS. THE SUBSEQUENT FOUR RERUNS GENERATED RESULTS OF 149,148, 149 AND 148 G/L (14.9, 14.8, 14.9, AND 14.8 G/DL) AND THESE RESULTS WERE GENERATED ON THE ANALYZER, HOWEVER, THESE RESULTS DID NOT COME ACROSS TO AMS. THE RERUN RESULTS ON AMS CAME UP AS 65 FOUR TIMES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873139 ↗
• MalfunctionOct 16, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT ALINIQ AMS WAS INVOLVED WITH AN EVENT IN WHICH PATIENTS' RESULTS WERE INTEGRATED TO ANOTHER PATIENT'S RESULTS. THE FOLLOWING SAMPLES INVOLVED TSH AND VITAMIN D: RESULTS FROM ID (B)(6) WERE TRANSMITTED TO ID (B)(6) RESULTS WERE TRANSMITTED TO ID (B)(6). THE CUSTOMER ALSO REPORTED THAT ID (B)(60 AS BEING RELATED TO THIS EVENT. THE PATIENTS ARE FEMALE. THE FOLLOWING INVOLVED POTASSIUM: POTASSIUM RESULTS OF 4.2941MMOL/L FROM ID (B)(6) WERE TRANSMITTED TO ID (B)(6), WITH A RESULT OF 2.6105 MMOL/L. THE RESULTS WERE IN THE CUSTOMER'S LABORATORY INFORMATION SYSTEM AND WAS NOT REPORTED OUT TO THE PATIENT HEALTHCARE PROVIDER. DURING THIS THE PATIENT RESULT EVENT, THE COMPUTER THAT WAS HOSTING THE ALINIQ AMS CRASHED AND LOST CONNECTION. 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 23310860 ↗
• MalfunctionOct 9, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE RESUTLS IN ALINIQ AMS DIDN'T MATCH THE RESULTS FROM THE ANALYZER FOR SAMPLE ID (B)(6), WHICH IS FROM AN 82-YEAR-OLD FEMALE PATIENT. THE CUSTOMER REPORTED THAT THE SAMPLE WAS RUN ON ANALYZER (NAME: FPCAC4). WHEN THE CUSTOMER LOOKED AT THE RESULTS IN AMS, THE CUSTOMER NOTED THAT THE RESULTS WERE NOT THE SAME. THE CUSTOMER ALSO NOTED THAT AMS DISPLAYED THAT THE PATIENT SAMPLE WAS RUN ON ANOTHER ANALYZER (NAME: FPCAC5), HOWEVER THE SAMPLE ACTUALLY RUN ON ANALYZER (NAME: FPCAC4). THE CUSTOMER WENT TO THE ANALYZER (NAME: FPCAC4) AND PRINTED OUT THE SAMPLE RESULTS, WHICH WERE THE CORRECT RESULTS. THE CUSTOMER CONFIRMED THAT AMS DID NOT RELEASE ANY INCORRECT RESULTS. 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 23256344 ↗
• MalfunctionOct 2, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED AN ISSUE WITH THE ALINIQ AMS SOFTWARE BASE, VERSION 3.02. THE CUSTOMER STATED A PATIENT SAMPLE WITH AN ICTERIC INDEX OF > 711.999 SHOULD HAVE TRIGGERED THE HIL INDICES RULE TO GENERATE AND ICT COMMENT IN PLACE OF THE RESULT AND HOLD THE RESULT. THIS WAS NOT BEING PERFORMED FOR THE POTASSIUM TEST; THEREFORE, THE POTASSIUM RESULT WITH A HIGH ICTERIC INDEX WAS NOT BEING HELD, AND THE RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE ID PROVIDED WAS (B)(6), HOWEVER NO SPECIFIC TEST RESULTS WERE PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199558 ↗
• MalfunctionJun 13, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE ALINIQ AMS SOFTWARE AUTO-RELEASED INVALID WBC AND DIFFERENTIAL RESULTS, WHICH WERE GENERATED BY THE ALINITY HQ ANALYZER, FOR A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6): SEQ# (B)(4), (B)(6) 2025; WBC = 11.4 X 10E9/L (INVALIDATED WITH X); NEU = 7.07 X 10E9/L (INVALIDATED WITH X); NEU% = 62.3% (INVALIDATED WITH X); LYM = 2.91 X 10E9/L (INVALIDATED WITH X); LYM% = 25.6% (INVALIDATED WITH X); MONO = 1.25 X 10E9/L (INVALIDATED WITH X); MONO% = 11.0 % (INVALIDATED WITH X); EOS = 0.0 X 10E9/L (INVALIDATED WITH X); EOS% = 0.0% (INVALIDATED WITH X); BASO = 0.122 X 10E9/L (INVALIDATED WITH X); BASO% = 1.07% (INVALIDATED WITH X); IG = 0.001 X 10E9/L (INVALIDATED WITH X); IG% = 0.011 % (INVALIDATED WITH X); NRBC = 0.00 X 10E9/L (INVALIDATED WITH X); NR/W = 0.00 (INVALIDATED WITH X); RBC = 2.51 X 10E12/L (INVALIDATED WITH X); FLAG: VAR LYM FLAG; THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201269 ↗
• MalfunctionJun 7, 2025Installation-Related Problem; Installation-Related Problem

  THE CUSTOMER OBSERVED NEUTROPHIL RESULTS GOING ACROSS TO ALINIQ AMS AS A PERCENTAGE, NOT AS A COUNT. THE CUSTOMER STATED THAT THE NEUTROPHIL RESULTS AS A PERCENTAGE, AND NOT A COUNT, DIDN¿T ALLOW FOR THE CUSTOMER TO DETERMINE IF RESULTS WERE HIGH OR ABNORMAL FOR PATIENTS. THERE WERE THREE SAMPLE IDS PROVIDED (B)(4); HOWEVER, NO PATIENT RESULTS WERE PROVIDED. IT WAS NOTED THAT THE ISSUE WAS CAUSED BY THE ¿SEND TO LIS AFTER VALIDATION¿ BUTTON BEING SELECTED ON THE AMS CONFIGURATOR BY THE ABBOTT TECHNICAL SUPPORT SPECIALIST. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162299 ↗
• MalfunctionMay 20, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED THAT THE AMS IS SENDING NEUTROPHIL ABSOLUTE COUNTS AS PERCENTAGES. THIS OCCURRED DUE TO ¿SEND TO LIS AFTER VALIDATION¿ BUTTON/BOX ON THE AMS WAS CHECKED. ONCE THE ¿SEND TO LIS AFTER VALIDATION¿ BOX WAS UNMARKED, THE ISSUE WAS RESOLVED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052940 ↗
• MalfunctionApr 10, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT A RULE IN ALINIQ AMS WAS NOT CORRECT. THE CUSTOMER REPORTED THAT A WHEN A GLUCOSE GENERATED ERROR 1039 OR 1040, A 1:5 DILUTION SHOULD OCCUR. SAMPLE ID (B)(6) GENERATED AN ELEVATED GLUCOSE RESULT AND THIS RULE DID NOT WORK FOR SAMPLE ID (B)(6) IN WHICH IT SHOULD HAVE REPEATED THE TEST WITH A 1:5 DILUTION. UPON FURTHER REVIEW, THE AMS WAS SET-UP WITH A STANDARD CONFIGURATION BY ABBOTT PERSONNEL. THE RULE FOR GLUCOSE WHEN THE INSTRUMENT GENERATES ERROR/FLAG 1039 OR 1040 TO RERUN WITH 1:5 DILUTION WAS SET CORRECTLY, HOWEVER A SUBSEQUENT RERUN RULE FOR THE SAME ERROR/FLAG TO REPEAT WITH A DILUTION OF 1 WAS OVER-RIDDING THE GLUCOSE RULE. IT WAS REPORTED THAT THE SEQUENTIAL ORDER OF THE RULES HAVE NOW BEEN RE-ORDERED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21819176 ↗
• MalfunctionFeb 4, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED AN INCORRECT RESULT OF 99 MMOL/MOL FOR A1C REPORTED FROM THEIR LIS, LABTRACK. THE RESULTS GENERATED BY THE TOSOH HB WERE <6 FOR SID (B)(6). THE SAMPLE WAS PROCESSED 6 TIMES WITH RESULTS = SA1C <6 MMOL/MOL OR PRODUCING A BLANK RESULT WITH A FLAG ¿41¿ WHICH MEANS A LOW SA1C. THE CUSTOMER WAS UNABLE TO DETERMINE WHERE THE RESULT OF 99 MMOL/MOL WAS ENTERED BUT BELIEVES IT ORIGINATED FROM THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307362 ↗
• MalfunctionJan 23, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED A POTASSIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE INCORRECTLY ISSUED THE RESULT TO A FEMALE PATIENT WITH A DATE OF BIRTH OF (B)(6) WITH THE SAME SAMPLE ID. (B)(6)2024 SID (B)(6) WAS USED WHEN VALIDATING TOTAL AUTOMATION. ORIGINAL POTASSIUM RESULT ((B)(6)) = 7.643 MMOL/L (HIGH FLAG). THE SAME SAMPLE WAS RUN ON ((B)(6)) ON (B)(6)2024 WITH RESULT = >10.000 MMOL/L (>, PSHH FLAGS). (B)(6)2024 SID (B)(6), THE AMS SENT THE PREVIOUS POTASSIUM RESULT OF 7.6 MMOL/L FROM ALINITY TO THE LIS THAT WAS AUTOMATICALLY VALIDATED AND THE ACTUAL RESULT FOR THE PATIENT WITH SID (B)(6) = 4.3 MMOL/L. THE RESULTS WERE SENT TO LIS ON (B)(6)2024 AS A TEST SAMPLE (UNKNOWN SAMPLE). THE ACTUAL SAMPLE CREATION DATE WITH THE SAME SAMPLE ID IS (B)(6)2024. THE RESULTS SENT FOR THE TEST SAMPLE WERE STORED BY THE LIS AND WERE VISIBLE WHEN THE SAMPLE WAS CREATED. THE CUSTOMER REPORTED THE CAUSE OF THE ISSUE WAS DUE TO THE LIS BUFFERING; HOWEVER, FURTHER INFORMATION FROM THE CUSTOMER WAS THEY ARE UNCERTAIN WHETHER THE ISSUE IS THE AMS OR THE NON-ABBOTT LIS. THE PATIENT WAS GIVEN RESONIUM 15 GRAMS DISSOLVED IN WATER AS A ONE TIME DOSE AND FURESIS 20 MG INTRAVENOUSLY, AND THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219766 ↗
• MalfunctionOct 1, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED THAT HBSAG RESULTS ARE BEING REPORTED AS NEGATIVE ON THE AMS WHEN, THEY ARE POSITIVE. THE AMS IS CONFIGURED IN S/CO WHERE THE CUTOFF IS >1, WHILE THE INSTRUMENT IS RELEASING THE RESULT IN IU/ML WHERE THE CUTOFF IS >0.05. THEREFORE, THE RESULTS ARE BEING INCORRECTLY INTERPRETED IN AMS, SINCE THE RULE WAS NOT CONFIGURED PROPERLY. SINCE THE INSTALLATION, RESULTS BETWEEN 0.06 AND 1 WERE INTERPRETED AS "NEGATIVE" (B)(6) 2024 SAMPLE ID (B)(6) RESULT = 0.11, (B)(6) 2024 SAMPLE ID (B)(6) RESULT = 0.22, (B)(6) 2024 SAMPLE ID (B)(6) RESULT = 0.10, SAMPLE ID (B)(6) RESULT ON THE INSTRUMENT = REACTIVE, SHOWN AS NEGATIVE ON THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343220 ↗
• MalfunctionJul 11, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT A RETEST WAS PERFORMED FOR THE S-IGA ASSAY WITH A STD 1:5 DILUTION WHEN IT SHOULD HAVE PROCESSED THE SAMPLE UNDILUTED. THE CAUSE WAS THE AMS SOFTWARE WAS CONFIGURED INCORRECTLY TO RUN AS 1:UNDILUTED, RERUN WITHOUT A DILUTION FACTOR SO THE INSTRUMENT RAN THE SAMPLE WITH THE STANDARD 1:5 DILUTION AS THIS IS THE DEFAULT FOR THIS ASSAY. DUE TO THE DILUTION THE RESULT WAS REPORTED BY AMS WAS <0.250 AND THE LIS REMOVED THE < CHARACTER AND RELEASED 0.250. THE CORRECT RESULT WAS <0.050. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723818 ↗
• MalfunctionDec 21, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED INCORRECT ALINIQ AMS SOFTWARE VERSION 3.01 CONFIGURATION AND PROVIDED THE FOLLOWING INFORMATION: CUSTOMER STATED THAT THERE HAVE BEEN OCCASIONS WHERE ELEMENTS OF SIGMA STRONG ASSAYS HAVE NOT BEEN COMPLETED CORRECTLY. MORE SPECIFICALLY, THE IMPACTED SIGMA STRONG ASSAYS HAVE NOT BEEN IMPLEMENTED WITH LINEAR RANGES. THE CUSTOMER REPORTED THAT THIS HAS BEEN ASSOCIATED WITH SEVERAL INCIDENTS LINKED TO PATIENT SAMPLES BEING REPORTED LATE AND/OR INCORRECTLY, HOWEVER THE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER REPORTED THAT ABBOTT PERSONNEL PERFORMED THE ALINIQ AMS CONFIGURATION IMPLEMENTATION AND THAT THE ASSAY PERFORMANCE WITH THE INSTRUMENT IS WITHIN EXPECTATIONS BASED ON VERIFICATION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377640 ↗
• MalfunctionAug 23, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED HIL INTERPRETATION WAS NOT UPDATED AFTER RERUN NOT HEMOLYZED SPECIMEN FROM ALINITY C PROCESSING MODULE WHICH CONNECTED TO ALNIQ AMS SOFTWARE. THE CUSTOMER DID NOT CENTRIFUGE THE PATIENT SPECIMEN AND RAN WHOLE BLOOD (HEMOLYZED) ON ALINITY C PROCESSING MODULE. THE SPECIMEN WAS NOT CENTRIFUGE SO PROVIDED >500 WITH TEXT GROSSLY HEMOLYZED. ACCORDING TO AMS SOFTWARE RULE GROSSLY HEMOLYZED SPECIMEN SHOULD HOLD FOR RERUN THAT RULE WORKED AND HELD SPECIMEN FOR RERUN. THE CUSTOMER CENTRIFUGED AND RERUN THAT SPECIMEN. THE SPECIMEN WAS NOT HEMOLYZED AFTER CENTRIFUGED AND GOT < 10. THE AMS SUPPOSED TO CHANGE TEXT TO FROM > 500 GROSSLY HEMOLYZED TO < 10 WITH NOT HEMOLYZED. THE AMS SOFTWARE REPORTED < 10 WITH INCORRECT GROSSLY HEMOLYZED TEXT TO LIS. THE INTERPRETATION DOES NOT MATCH WITH SPECIMEN CONDITION. THE CUSTOMER EXPECTED THAT IF <10 SHOULD CHANGE TEXT TO NOT HEMOLYZED. THE AMS SOFTWARE DID NOT PERFORM THE WAY SUPPOSED TO FOR INTERPRETATION ON NOT HEMOLYZED SPECIMEN. THE ABBOTT FSR CHANGED THE RULE IN AMS SOFTWARE. THE LIS SETTING CHANGED DUE TO AMS SOFTWARE RULE CHANGED. THE CUSTOMER CORRECTED THE NOT HEMOLYZED TEXT WITH PATIENT RESULTS. NO OTHER DISCREPANT PATIENT R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604553 ↗