QuickVueRecalls & reported problems across all models

Quidel Corporation · 6 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name at least one QuickVue model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports: 5,122
Deaths reported: 1
Injuries reported: 13
Recalls: 2

We found 6 models of QuickVue by Quidel Corporation in the FDA's device registry (GUDID). Together they are named in 5,122 adverse event reports in the FDA's MAUDE database, received between Feb 27, 2020 and Dec 16, 2025 — classified as 1 death, 13 injuries, 5,108 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2,995 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

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

QuickVue recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

Apr 6, 2026Open, Classified
Product has the potential for false positive results
Z-2169-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Jun 17, 2025Open, Classified
Dipstick strep A test has potential for false positive results.
Z-2545-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported QuickVue problems

Device problems

No Apparent Adverse Event5,121
False Positive Result2,995
False Negative Result348
Imprecise or Erratic Results281
Incorrect, Inadequate or Imprecise Result or Readings11
Non Reproducible Results6

Patient problems

No Clinical Signs, Symptoms or Conditions4,981
Insufficient Information1,400
Chronic Obstructive Pulmonary Disease (COPD)1
Death1
Eye Irritation1
Pulmonary Emphysema1
Sudden Cardiac Death1

QuickVue models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

QuickVue 20402
Coronavirus antigen detection test system.
4,225 reports
QuickVue 20387
Coronavirus antigen detection test system.
686 reports
QuickVue 20398
Coronavirus antigen detection test system.
210 reports
QuickVue 20108
ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
2 recalls0 reports
QuickVue 20125
ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
1 recall0 reports
QuickVue 20183
ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
1 death1 report

Recent QuickVue adverse event reports

The 15 most recent reports across all models, 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 ↗
MalfunctionSep 15, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
ONLINE CUSTOMER REVIEW REPORTS 2 FALSE POSITIVE RESULTS COMPARED TO OTHER RAPID TEST AND UNSPECIFIED PHYSICIAN TEST. FREQUENCY NOT PROVIDED. NOT SPECIFIED IF SYMPTOMATIC OR ASYMPTOMATIC. NO OTHER INFORMATION PROVIDED. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052775 ↗
MalfunctionSep 15, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
ONLINE CUSTOMER REVIEW REPORTS 2 FALSE POSITIVE RESULTS COMPARED TO OTHER RAPID TEST AND UNSPECIFIED PHYSICIAN TEST. FREQUENCY NOT PROVIDED. NOT SPECIFIED IF SYPTOMATIC OR ASYMPTOMATIC. NO OTHER INFORMATION PROVIDED. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052774 ↗
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 ↗

Other Quidel Corporation products

All Quidel Corporation devices →

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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