Devices Detecting Influenza A, B, And C Virus Antigens
FDA adverse event reports and recall history for devices detecting influenza a, b, and c virus antigens (product code PSZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 169
- Deaths
- 3
- Injuries
- 3
- Malfunctions
- 162
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-02-09Open, ClassifiedUnder Investigation by firm
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.
- TerminatedProcess control
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Due to false positive results.
- TerminatedSoftware Manufacturing/Software Deployment
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
- TerminatedUnder Investigation by firm
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
- TerminatedUnder Investigation by firm
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
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