The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design tha...

FDA Device Recall #Z-1086-2024 — Class II — January 3, 2024

Recall Summary

Recall Number Z-1086-2024
Classification Class II — Moderate risk
Date Initiated January 3, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Quidel Corporation
Location Carlsbad, CA
Product Type Devices
Quantity 312 Kits

Product Description

The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

Reason for Recall

One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.

Distribution Pattern

US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.

Lot / Code Information

UDI-DI: 30014613339229. Lot: 709083

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-1308-2023 Class II MicroVue C1-Inhibitor Plus EIA for measuring th... Feb 1, 2023
Z-2477-2021 Class II Lyra Direct SARS-CoV-2 Assay Emergency Use Auth... Aug 13, 2021

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.