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QuickVue 20398Recalls & reported problems

Quidel Corporation · QuickVue At-Home OTC COVID-19 Test · Class N

Quick summary

This Quidel QuickVue At-Home COVID test is an over-the-counter test used at home. The largest group of its 210 reports (70) describes false positive results, meaning positive readings the reports say were wrong; a few describe false negatives or unclear results. The reports include no deaths or injuries. No recalls name this device. No reports came in the last 12 months, versus 134 in the 12 months before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
210
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 210 adverse event reports that list this exact device (DI 30014613339670), received between Dec 14, 2021 and Sep 2, 2025 — classified as 210 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (70 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.

Reports received per month

Nov 2023: 13 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 10 reportsDec 2024: 0 reportsJan 2025: 7 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 17 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 80 reportsSep 2025: 20 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202680
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • No Apparent Adverse Event210
  • False Positive Result70
  • False Negative Result6
  • Imprecise or Erratic Results4

Patient problems

  • No Clinical Signs, Symptoms or Conditions201
  • Insufficient Information12

Recent adverse event reports

The 25 most recent of 210 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 99 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22938330 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 96 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22938315 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 83 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22938289 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 100 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937875 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 98 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937861 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 92 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937854 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 95 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937842 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO. APPARENT ADVERSE EVENT. REPORT 89 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937834 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 91 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937828 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO. APPARENT ADVERSE EVENT. REPORT 84 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937818 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 90 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937808 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO. APPARENT ADVERSE EVENT. REPORT 81 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937806 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 97 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937795 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 82 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937793 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 93 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937788 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 94 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937781 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 88 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937771 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 86 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937768 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 87 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937764 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 85 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22937757 ↗
  • MalfunctionAug 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 76 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22927191 ↗
  • MalfunctionAug 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 74 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22927189 ↗
  • MalfunctionAug 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 80 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22927188 ↗
  • MalfunctionAug 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 77 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22927187 ↗
  • MalfunctionAug 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REPORTS FALSE POSITIVE RESULTS OVER SEVERAL MONTHS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. CONFIRMATION NOT PERFORMED. NO APPARENT ADVERSE EVENT. REPORT 78 OF 100.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22927185 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.