QuickVue 20387Recalls & reported problems

Quidel Corporation · QuickVue® SARS Antigen Test · Class N

Quick summary

This Quidel QuickVue SARS antigen test has 686 adverse event reports, with no deaths and 2 injuries. Most describe false positive results, and a few were confirmed as false by PCR testing. No recalls name this device. Reports dropped sharply, with 2 in the last year compared with 80 in the year 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: 686
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 686 adverse event reports that list this exact device (DI 30014613339373), received between Feb 16, 2022 and Dec 16, 2025 — classified as 2 injuries, 684 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (605 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Apparent Adverse Event686
False Positive Result605
False Negative Result40
Imprecise or Erratic Results10

Patient problems

No Clinical Signs, Symptoms or Conditions604
Insufficient Information113

Recent adverse event reports

The 25 most recent of 686 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 16, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
REPORTS 2 FALSE POSITIVE RESULTS CONFIRMED WITH PCR. UNKNOWN IF PATIENT WAS SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822521 ↗
MalfunctionDec 16, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
REPORTS 2 FALSE POSITIVE RESULTS CONFIRMED WITH PCR. UNKNOWN IF PATIENT WAS SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822520 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 20 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347412 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 16 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347343 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 19 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347339 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 21 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347298 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 15 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347287 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 13 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347261 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 17 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347258 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 18 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347255 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 12 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347215 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 11 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347194 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 10 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347189 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 14 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347188 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 7 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347168 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 9 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347149 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 6 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347140 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 8 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347136 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 5 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347118 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 4 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347115 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 3 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347112 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347107 ↗
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 21 EVENTS OF FALSE POSITIVE RESULTS. NO CONFIRMATION PERFORMED. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21347098 ↗
InjuryFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 2 EVENTS OF BLOOD ON SWAB AFTER SAMPLE COLLECTION. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21345948 ↗
InjuryFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
REPORTS 2 EVENTS OF BLOOD ON SWAB AFTER SAMPLE COLLECTION. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21345940 ↗

Device details

UDI-DI	`30014613339373`
Brand	QuickVue
Model	20387
Company	Quidel Corporation
Product code	QKP · Coronavirus antigen detection test system.
Class	Class N
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 24, 2025

Device type (GMDN): SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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