Alinity 06P0161Recalls & reported problems
Abbott Laboratories · Alinity s HIV Ag/Ab Combo Reagent Kit
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740202859), received between Sep 3, 2026 and Sep 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive 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 Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026False Positive Result
The customer observed false reactive Alinity s HIV Ag/Ab Combo and provided the following data:Sample ID (b)(6) results are 1.84, 2.84, and 2.86. NAT: Negative.Sample ID (b)(6) results are 1.41, 1.43, and 1.49. NAT: Negative.Sample ID (b)(6) results are 1.07, 2.35, and non-reactive (result not provided). NAT: Negative.Sample ID (b)(6) results are 1.00, 6.66, and non-reactive (result not provided). NAT: Negative.Sample ID (b)(6) results are 15.65, 34.64, and 4.10. NAT: Negative.Sample ID (b)(6) results are 13.15, 18.05, and 30.90. NAT: Negative.Sample ID (b)(6) results are 4.04, 4.06, and 6.20. NAT: Negative.Sample ID (b)(6) results are 10.93, 19.58, and 20.23. NAT: Negative.Sample ID (b)(6) results are 37.48, 45.01, and 43.48. NAT: Negative.No results were provided for Sample IDs (b)(6) and (b)(6).The customer reported that all samples generated Negative NAT results. The customer further communicated that the samples were for the purpose of tissue donation, however the customer confirmed 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 50595564 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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