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.
Enforcement
- Recall Number
- Z-0124-2021
- Event ID
- 86276
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Quidel Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 28, 2020
- Initiation Date
- September 17, 2020
- Classification Date
- October 19, 2020
- Termination Date
- August 9, 2022
- Address
- 10165 McKellar Ct, N/A, San Diego, CA, 92121-4201, United States
Description
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.
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.
1438900EN00 (03/20) and 1438901EN00 (05/20)
U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO.
10537