Quidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors
Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error that may result in false-positive test results. This aligns with the rubric for moderate severity, which includes minor labeling errors or low-risk contamination where no direct physical injury is reported.
Plain-English summary
Quidel Corporation is recalling the package inserts for the Sofia SARS Antigen FIA test. The recall involves 10,537 units of the package inserts, which are used with the Sofia and Sofia 2 instruments for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimens.
The recall was initiated because the instructions for use in the package insert were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. The source text states that the use of the specific viral transport medium products may result in false-positive results. Directly testing from specimens (nasal or nasopharyngeal swab) is recommended.
The affected package inserts were distributed nationwide in the United States, including in states such as New York, Kansas, Texas, Alabama, Florida, Minnesota, California, Illinois, Massachusetts, Mississippi, Pennsylvania, Georgia, New Hampshire, Missouri, Virginia, Michigan, Oregon, West Virginia, Oklahoma, Nevada, Connecticut, Tennessee, Maryland, Louisiana, Arkansas, Hawaii, New Jersey, Kentucky, Vermont, Iowa, Rhode Island, New Mexico, Ohio, Indiana, Alaska, South Carolina, North Carolina, Arizona, South Dakota, Nebraska, Wisconsin, and Colorado. The specific lot codes involved are 1438900EN00 (03/20) and 1438901EN00 (05/20).
The recalled product
- Product
- 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…
- Manufacturer
- Quidel Corporation
- Affected units
- 10,537
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1438900EN00 (03/20) and 1438901EN00 (05/20)
Distribution
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