Devices Detecting Influenza A, B, And C Virus Antigens

BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings.

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.

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Due to false positive results.

Sofia 2 Analyzer Catalog Number 20299

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.

BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices.

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

BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices

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