OraQuick In Home HIV Test 1001-0340Recalls & reported problems
Orasure Technologies, Inc. · Class 2
Data updated Oct 18, 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 00608337103403), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2024
RECEIVED A FALSE POSITIVE TEST RESULT ON AN ORAQUICK IN-HOME HIV TEST. LOT NUMBER 006711890A. EXPIRATION DATE 2026-01-31. AS FAR AS I AM AWARE I FOLLOWED ALL INSTRUCTIONS PROPERLY. I WANTED TO REPORT THIS JUST TO RECORD IN THE FIELD USE FAULT OF THE PRODUCT, IN CASE THE LOT WAS CONTAMINATED/DAMAGED BEFORE DISTRIBUTION. ALSO REPORTED TO ORAQUICK COMPANY ITSELF.
Patient problems: Insufficient Information
MAUDE report 20091242 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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