AlinIQ 03R89-47Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740189907), received between Dec 28, 2020 and Apr 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED NEGATIVE RESULT VALUES FOR HEMOGLOBIN, HEMATOCRIT, AND MCV IN THE ALINIQ AMS SOFTWARE, WHICH WERE RELEASED INTO THE LABORATORY INFORMATION SYSTEM. THE CUSTOMER USES THE ALINITY HQ ANALYZER FOR PATIENT BLOOD AND STEM CELLS. IN THE ALINIQ AMS SOFTWARE, THERE WAS A RULE SET UP TO DISTINGUISH THESE SAMPLE TYPES (X AND *). AFTER THE ALINITY HQ ANALYZER SOFTWARE UPGRADE, THE RULE NO LONGER FUNCTIONED CORRECTLY. BOTH FLAGS (X AND *) APPEARED TOGETHER, CAUSING THE RESULT TO GO FROM 0.00 TO -1. THE RESULTS EXAMPLE PROVIDED WERE AS BELOW: SID 7925347373 HEMATOCRIT FROM ALINITY HQ=1.41X* /TRANSMITTED TO LIS BY AMS=-1 SID 8001697273 HEMATOCRIT FROM ALINITY HQ=0.00X* / TRANSMITTED TO LIS BY AMS=-1; HEMOGLOBIN FROM ALINITY HQ=0.024X* / TRANSMITTED TO LIS BY AMS=-1; MCV FROM ALINITY HQ=0.00X* / TRANSMITTED TO LIS BY AMS=-1 THE ABBOTT FSR RECONFIGURED AMS RULE TO COVER BOTH FLAGGING AFTER NEW SOFTWARE UPGRADE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920866 ↗
• MalfunctionFeb 23, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER STATED FALSELY DECREASED HEMOGLOBIN AND MCHC RESULTS WERE RELEASED BY THE ALINIQ AMS BASE SOFTWARE. THE CUSTOMER STATED THE RESULTS WERE GENERATED ON THE ALINITY HQ ANALYZER AND WERE FLAGGED WITH AN ¿X¿ WHICH INDICATED THAT THE RESULTS WERE INVALIDED. THE ALINIQ AMS RELEASED THE RESULTS, AND THE RESULTS WERE REPORTED TO THE PHYSICIANS. THE CUSTOMER HAS CORRECTED THE HEMOGLOBIN RESULTS. THE CUSTOMER STATED SOME OF THE PATIENTS HAD TO HAVE A NEW BLOOD DRAW. THE CUSTOMER IS USING THE OPTICAL HEMOGLOBIN (CHGB) AS THE CORRECT VALUES. THE FOLLOWING DATA WAS PROVIDED: HEMOGLOBIN REFERENCE RANGES: 0-8 DAYS: 8.5 TO 12.5 MMOL/L; 8 DAYS-6 YEARS: 6.0 TO 9.0 MMOL/L; 7 YEARS-15 YEARS: 6.5 TO 10.0 MMOL/L; MALE >15 YEARS: 8.5 TO 11.0 MMOL/L; FEMALE >15 YEARS: 7.5 TO 10.0 MMOL/L. MCHC REFERENCE RANGE = 19.0 TO 23.0 MMOL/L. ALL THE FOLLOWING RESULTS WERE GENERATED ON (B)(6) 2023. (B)(6). SID (B)(6) MCHC = 15.2 MMOL/L; HGB = 7.05 MMOL/L; HGB CORRECTED TO = 9.45 MMOL/L. FOR THIS SAMPLE, THE SAMPLE REPORT SHOWED ALL RESULTS FLAGGED WITH AN ¿X¿ WHICH INVALIDATED THE RESULTS. HGB INTERFERENCE FLAG ALSO PRESENT. OTHER SYSTEM MESSAGES WERE MCHC OUT OF RANGE; CHECK SAMPLE INTEGRITY; NRBC BOUNDA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427404 ↗
• MalfunctionDec 28, 2020Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THE INCORRECT ASSAY WAS RAN WHILE USING THE ALINIQ AMS SOFTWARE. SAMPLE ID: (B)(6) GENERATED A FOLATE RESULT OF 101.71 FROM AN ANALYZER THAT DID NOT HAVE A FOLATE REAGENT INSTALLED. THE RESULT WAS ACTUALLY FERRITIN AND NOT THE ORDERED FOLATE. REVIEW OF THE INCIDENT FOUND THE MAPPING OF THE ALINIQ AMS HAD A CONFIGURATION ERROR IN WHICH THE FOLATE TEST WAS CONFIGURED WITH THE FERRITIN ASSAY CODE. ADDITIONALLY, A SIMILAR ERROR WAS IDENTIFIED FOR THE URINE TOTAL PROTEIN WHICH HAD THE ASSAY CODE FOR URINE PHOSPHATASE. A LOOK BACK WAS PERFORMED, AND 170 FOLATE PATIENT RESULTS WERE IMPACTED AND 31 URINE TOTAL PROTEIN RESULTS WERE IMPACTED. TO DATE, THERE HAS BEEN NO REPORT OF ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11076190 ↗