Alinity 08P0721Recalls & reported problems
Abbott GmbH · Alinity i HIV Ag/Ab Combo Reagent Kit 200 Tests · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740121754), received between Apr 25, 2023 and Sep 10, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
- False Positive Result1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I HIV AG/AB COMBO RESULTS WERE GENERATED FOR A 64-YEAR-OLD MALE PATIENT WHO WAS IN SURGERY READY AND WAITING TO RECEIVE A HEART TRANSPLANT. THE PATIENT DID NOT RECEIVE THE HEART TRANSPLANT DUE TO THEIR REACTIVE HIV RESULTS. THE PATIENT REMAINED ADMITTED IN THE HOSPITAL AND LATER RECEIVED ANOTHER DONATED HEART APPROXIMATELY 2 DAYS LATER.
Patient problems: Insufficient Information
MAUDE report 23017089 ↗MalfunctionApr 25, 2023False Negative Result; False Negative Result
THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULT FOR ONE PATIENT. THE ALINITY I HIV AG/AB COMBO RESULT WAS NONREACTIVE FOR SID (B)(6), AND A VIRAL LOAD WAS ALSO ORDERED. THE VIRAL LOAD RESULT WAS ¿DETECTED, 60000 COPIES/ML¿. THE DOCTOR THEN ASKED TO RETEST THE HIV SAMPLE ON THE ALINITY AND THE RETEST RESULT WAS ALSO NONREACTIVE. THE PATIENT HAD ANOTHER SPECIMEN COLLECTED 2 DAYS LATER AND RESULTED 7.55 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16809679 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.