Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

QUIDEL Sofia SARS Antigen FIA IVD REF 20374 Recalled by Quidel Corporation Due to Due to false positive results.

Date: September 25, 2020
Company: Quidel Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Quidel Corporation directly.

Affected Products

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Quantity: 8,628 kits

Why Was This Recalled?

Due to false positive results.

Where Was This Sold?

This product was distributed to 23 states: AL, AZ, AR, CA, FL, GA, IN, LA, MS, MO, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY

Affected (23 states)Not affected

About Quidel Corporation

Quidel Corporation has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report