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Sofia 20260Recalls & reported problems

Quidel Corporation · Sofia RSV 25T, US · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30014613202608), received between Jan 24, 2020 and Jan 24, 2020 — classified as 1 injury.

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

  • Respiratory Tract Infection1

Recent adverse event reports

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

  • InjuryJan 24, 2020False Negative Result; False Negative Result

    ON (B)(6), AN INFANT WITH RSV-LIKE SYMPTOMS TESTED NEGATIVE FOR RSV AT THE ER AND WAS SENT HOME. ON (B)(6) THE INFANT WAS BROUGHT BACK TO THE ER AND TESTED NEGATIVE FOR RSV AGAIN. THE PATIENT WAS THEN TRANSFERRED SAME DAY TO (B)(6) AND WAS TESTED WITH THE BIOFIRE RP PANEL. THE PCR CAME BACK POSITIVE FOR RSV. THE INFANT DEVELOPED PNEUMONIA AND WAS RUSHED INTO THE ICU SAME DAY (12/26) WAS RELEASED ON (B)(6) 2019.

    Patient problems: Respiratory Tract Infection

    MAUDE report 9627958 ↗

Other ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS devices

All ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS devices →

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