Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluo...

FDA Device Recall #Z-0124-2021 — Class II — September 17, 2020

Recall Summary

Recall Number Z-0124-2021
Classification Class II — Moderate risk
Date Initiated September 17, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Quidel Corporation
Location San Diego, CA
Product Type Devices
Quantity 10537

Product 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.

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 Pattern

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.

Lot / Code Information

1438900EN00 (03/20) and 1438901EN00 (05/20)

Other Recalls from Quidel Corporation

Recall # Classification Product Date
Z-2545-2025 Class II QuickVue: Dipstick Strep A Test: 50T, REF: 2010... Jun 17, 2025
Z-1636-2024 Class II QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U... Mar 5, 2024
Z-1637-2024 Class II QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, ... Mar 5, 2024
Z-1086-2024 Class II The Sofia 2 Flu + SARS Antigen FIA employs immu... Jan 3, 2024
Z-1308-2023 Class II MicroVue C1-Inhibitor Plus EIA for measuring th... Feb 1, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.