AlinIQ 03R8965Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740212575), received between Apr 2, 2025 and Mar 9, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Computer Software Problem

  THE CUSTOMER OBSERVED THE ALINIQ AMS REPORTED THE HPVOTHER, WHICH IS A COMBINED PLACEHOLDER FOR THE HPV OTHER A AND HPV OTHER B, AS NEGATIVE RESULT EVEN THOUGH THE HPV RESULT WAS OTHER HR HPV A, SHOULD HAVE RESULTED AS POSITIVE. HPV ¿OTHER¿ RESULTS ARE CONSOLIDATED INTO A SINGLE OUTPUT TEST (HPVOTHER), WHICH CONFLICTED WITH THE EXISTING VALIDATION RULE BY EVALUATING MULTIPLE OUTCOMES (OTHER A AND OTHER B) AGAINST ONE COMBINED RESULT. ALL PATIENT RESULTS WERE BLOCKED AND HELD IN THE LIS AND NO RESULTS WERE RELEASED OUT OF THE LABORATORY. A QPL ADJUSTMENT WAS IMPLEMENTED TO ENSURE THE RULE CORRECTLY INTERPRETS THE COMBINED HPV OTHER RESULTS AND PRODUCES A CONSISTENT OUTCOME. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544175 ↗
• MalfunctionJan 6, 2026Computer Software Problem

  THE CUSTOMER REPORTED THE ALINIQ AMS AUTO-VALIDATED A DISCREPANT ALINITY I AFP (ALPHA1 FETOPROTEIN) RESULT FOR ONE PATIENT SAMPLE. MULTIPLE SAMPLES WERE BEING RUN FOR THE ALINITY I AFP (ALPHA1 FETOPROTEIN) AND THE ANALYZER GENERATED ERROR CODE 1094 - UNABLE TO PROCESS TEST, NO REAGENT CARTRIDGE AVAILABLE. ALL SAMPLES WERE REPEATED WITH A DILUTION FACTOR UPDATED BY THE USER, AND GENERATED RESULTS OF <16.6. FOUR OUT OF FIVE OF THE SAMPLES WERE HELD IN AMS AND MANUALLY VALIDATED BY THE CUSTOMER, AND ONE SAMPLE AUTO-VALIDATED. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) - RESULT VALIDATED BY USER = <16.6, CORRECT RESULT = 4.7. SID (B)(6) - VALIDATED BY USER = <16.6, CORRECT RESULT = <1.7. SID (B)(6) - VALIDATED BY USER = <16.6, CORRECT RESULT = 9.5. SID (B)(6) - AUTO-VALIDATED RESULT = <16.6, CORRECT RESULT = 4.8. SID (B)(6) - VALIDATED BY USER = <16.6, CORRECT RESULT = 5.7. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973549 ↗
• MalfunctionApr 15, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED DISCREPANCIES IN HBSAG RESULTS FOR TWO SAMPLES (SID (B)(6) WHERE THE AMS SYSTEM REPORTED A VALUE OF 54, WHICH DIFFERS SIGNIFICANTLY FROM THE ORIGINAL VALUES (100.862 AND 5821.777, RESPECTIVELY). THE RESULTS WERE INCORRECT DUE TO MANUALLY OVERWRITING OR INSERTED WITH THE BARCODE SCANNER. ADDITIONALLY, THE BARCODE SCANNERS AT THE AMS WORKSTATIONS WERE DISABLED DUE TO CONTINUOUS SCANNING OF RANDOM BARCODES, WHICH COULD INADVERTENTLY ALTER SAMPLE RESULTS. MANUAL EDITS WERE FOUND IN THE EVENT HISTORY FOR VARIOUS SPECIMENS, ALL LINKED TO THE AMS USER ACCOUNT "A". THE EXAMPLES OF THIS WERE PROVIDED: SAMPLE: (B)(6), SPECIMEN: ANTI-HCV, RESULT: 1537.00. SPECIMEN: ALBBCG, RESULT: 15.00, REQUEST: 270325436. SPECIMEN: CHE, RESULT: 9.29, REQUEST: 030425113. SPECIMEN: ALKP, RESULT: 78.00, REQUEST: 270325019. SPECIMEN: ALT, RESULT: 78.00, REQUEST: 270325019. SPECIMEN: AST, RESULT: 78.00, REQUEST: 270325019. THE CUSTOMER CONFIRMED THAT THE INCORRECT RESULTS WERE NOT RELEASED OUT OF THE LAB. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21844270 ↗
• MalfunctionApr 2, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THE ALINIQ AMS WILL CANCEL THE HIL INDEX (HEMOLYSIS, ICTERIC, LIPEMIA) ORDER ON SAMPLES THAT HAD A CORRESPONDING ASSAY THAT WAS CANCELED. THIS WAS IDENTIFIED WHEN THE CUSTOMER FOUND MULTIPLE SAMPLES THAT HAD NO HIL MEASUREMENTS COMPLETED ON THEM. AFTER FURTHER REVIEW, AN ALINIQ AMS RULE WAS CONFIGURED INCORRECTLY. THIS RULE IS RESPONSIBLE FOR ADDING HIL ORDERS TO CERTAIN DEFINED TESTS THAT THE LIS SENDS TO THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751073 ↗