AlinIQ 03R89-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740145125), received between Oct 31, 2022 and Feb 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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

• MalfunctionFeb 3, 2025Data Problem; Data Problem

  THE CUSTOMER OBSERVED A RESULT MISMATCH FOR TWO PATIENT SAMPLES BY THE ALINITY CI-SERIES SYSTEM CONTROL MODULE AND THE ALINIQ AMS SOFTWARE. THE CUSTOMER REPORTED THAT AN INCORRECT MICROALBUMIN RESULT FOR SID: (B)(6) WAS RELEASED BY THE ALINITY CI-SERIES SYSTEM CONTROL MODULE INTO THE ALINIQ AMS SOFTWARE FOR A PATIENT. ON (B)(6) 2025, SID: (B)(6) GENERATED A MICROALBUMIN RESULT OF <5.0 MG/L, WHICH WAS RELEASED INTO THE ALINIQ AMS SOFTWARE. THE NEXT SAMPLE, SAMPLE ID: (B)(6), GENERATED A MICROALBUMIN RESULT OF 28.5 MG/L, WHICH WAS RELEASED INTO THE ALINIQ AMS SOFTWARE UNDER SID: (B)(6). CONSEQUENTLY, THE MICROALBUMIN RESULT FOR SID: (B)(6) WAS REPORTED OUT OF THE LAB AS 28.5 MG/L (INCORRECT RESULT) INSTEAD OF <5.0 MG/L (CORRECT RESULT). THE CUSTOMER HAS SINCE AMENDED THE PATIENT REPORT. THE ABBOTT SERVICE TEAM WAS UNABLE TO DETERMINE IF THE ISSUE WAS CAUSED BY THE ALINIQ AMS SOFTWARE OR THE ALINITY CI-SERIES SYSTEM CONTROL MODULE, SO THIS INCIDENT WILL BE REPORTED UNDER BOTH PRODUCTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294803 ↗
• MalfunctionFeb 20, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED MISMATCHED RESULTS THAT WERE AUTOMATICALLY VALIDATED ON ALINIQ SOFTWARE VERSION V2.10. THERE WAS A REVERSAL OF RESULTS BETWEEN THE PSA, TOTAL AND PSA, FREE ASSAY. A QPL RESULT OF 1.003 FOR PSA, TOTAL WAS AUTOMATICALLY VALIDATED EVEN THOUGH IT DID NOT CORRESPOND TO ANY RESULTS OUTPUT FROM THE MACHINE. IT WAS DETERMINED THAT THERE WAS AN ERROR IN THE CONFIGURATION RULES THAT WAS IMMEDIATELY IDENTIFIED BY AN ABBOTT EMPLOYEE AND CORRECTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737902 ↗
• MalfunctionOct 31, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED AFTER SAMPLES WERE LOADED ON THE ALINITY I PROCESSING MODULE, A REQUEST WAS DENIED. THE TECHNICIAN WAS ON SITE TO TROUBLESHOOT THE AMS CONNECTION. WHILE THE TECHNICIAN WAS ASSISTING THE REMOVAL OF THE SPECIMEN FROM THE ALINITY I TO BE PLACED ON THE COUNTER, THE SPECIMEN TUBE SLIPPED OUT OF THEIR HAND. IT WAS REPORTED THE SERUM SPRINKLED ON THEIR ARM. THE TECHNICIAN WAS WEARING GLOVES AND A MASK AT THE TIME OF THE EVENT. WHILE THE TECHNICIAN WAS RINSING AND DISINFECTING THEIR ARM, THE UNCLOTTED WOUND ON THEIR HAND WAS EXPOSED. THE SAMPLE WAS TESTED USING THE PREOPERATIVE 8-ASSAY PANEL. THE RESULTS WERE: HEPATITIS B FIVE-ASSAY PANEL WAS POSITIVE FOR 1, 3, AND 5 [HBSAG, HBEAG, AND HBCAB], AND NEGATIVE FOR AIDS, HEPATITIS C, AND SYPHILIS. THE TECHNICIAN HAD BLOOD DRAWN AND WAS TESTED USING THE PREOPERATIVE 8-ASSAY PANEL AT THE LABORATORY. THE HEPATITIS B FIVE-ASSAY PANEL WAS POSITIVE FOR 2 AND 5 [HBSAB AND HBCAB], AND NEGATIVE FOR AIDS, HEPATITIS C, AND SYPHILIS. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. ADDITIONALLY, IT WAS REPORTED THAT THE AMS COMMUNICATION WAS NORMAL; HOWEVER, LIS DID NOT SEND THE REQUEST TO AMS. THIS RETURNED TO NORMAL AFTER CONTAC

  Patient problems: Exposure to Body Fluids

  MAUDE report 15698098 ↗