Sofia 20218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30014613202189), received between Feb 28, 2018 and Feb 28, 2018 — classified as 1 death.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 other recall cover devices cleared under the same FDA submission (K112177); they may or may not involve this specific model.

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

Recent adverse event reports

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

• DeathFeb 28, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, THE CHIEF MEDICAL OFFICER OF (B)(6) HEALTHCARE CONTACTED QUIDEL REGARDING A PATIENT WHO WAS TESTED FOR INFLUENZA WITH THE SOFIA INFLUENZA A+B FIA. THE TESTING OCCURRED ON (B)(6) 2018 AT THE (B)(6) IMMEDIATE CARE FACILITY ((B)(6) LOCATION). THE TEST RESULTS WERE NEGATIVE FOR INFLUENZA A AND INFLUENZA B. ON (B)(6) 2018, THE PATIENT WAS LIFE-FLIGHTED TO A HOSPITAL AND TESTED POSITIVE FOR INFLUENZA. ON (B)(6) 2018, THE PATIENT PASSED AWAY AT THE HOSPITAL.

  Patient problems: Respiratory Tract Infection

  MAUDE report 7304598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112177. One submission often covers many models, so check the product and lot details in each record.

• Z-0819-2013 · Dec 3, 2012 · Terminated
  Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.