# FDA recall Z-0124-2021

> **Quidel Corporation** · Class II · device recall initiated 2020-09-17.

## 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 (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.

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0124-2021
- **Recalling firm:** Quidel Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-17
- **Report date:** 2020-10-28
- **Termination date:** 2022-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0124-2021

## Citation

> AI Analytics. FDA recall Z-0124-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0124-2021. Source: US FDA. Licensed CC0.

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