Reported Oct 28, 2020 · Terminated
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay…
Quidel Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quidel Corporation · 10165 McKellar Ct · San Diego, CA · 92121-4201
Is this the product you have?
- 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.
- Lot codes and dates
- 1438900EN00 (03/20) and 1438901EN00 (05/20)
- Amount recalled
- 10537
Where it was sold
Why it was recalled
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
This product could cause temporary or reversible health problems — stop using it.
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