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QuickVue 20183Recalls & reported problems

Quidel Corporation · QkVue Flu A+B 25T, CE · Class 1

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30014613201830), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 death.

The most frequently reported specific device problem is “False Negative 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.

Most reported problems

Device problems

  • False Negative Result1

Patient problems

  • Death1
  • Sudden Cardiac Death1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathFeb 27, 2020False Negative Result; False Negative Result

    VERY SICK PATIENT CAME INTO THE CLINIC ON JAN 22 AND TESTED NEGATIVE FOR FLU WITH QUICKVUE TEST. HE WAS PRESCRIBED AZITHROMYCIN BECAUSE THEY BELIEVED HE HAD PNEUMONIA. ON JAN 23, A CHECK-IN WAS PERFORMED AND HE STATED HE WAS FEELING BETTER. ON JAN 24TH, 9:45 AM, HE CALLED IN REPORTING TO FEEL WORSE AND DEHYDRATED. HE DROVE TO THE HOSPITAL (B)(6) MEDICAL CENTER AND ARRIVED TO THE ER AT 2:56 PM. HE TESTED POSITIVE FOR FLU A ON MOLECULAR TEST (SOLANA) AND DIED LATER THAT DAY DUE TO CARDIAC ARREST.

    Patient problems: Death; Sudden Cardiac Death

    MAUDE report 9766131 ↗

Other ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C devices

All ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C devices →

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