Quidel Corporation: Medical Device Recalls in 2020

According to to data from the FDA, there were 2 medical device recalls made by Quidel Corporation in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
• QUIDEL Sofia SARS Antigen FIA IVD REF 20374