CLASS II Device recall · Reported 18 Nov 2020 · FDA Enforcement Report

Sofia SARS Antigen FIA IVD recalled by Quidel

Quidel is recalling Sofia SARS Antigen FIA IVD, distributed in 23 states. The recall was initiated on 25 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817

Quantity recalled8,628 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0428-2021
FDA event ID: 86550
Recalling firm: Quidel, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 25 Sep 2020
FDA classified: 6 Nov 2020
Reported: 18 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

25 Sep 2020	Recall initiated by company
6 Nov 2020	Classified by FDA	+42 days
18 Nov 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to false positive results.

Product as listed by the FDA

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Where it was distributed

U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY

Alabama Arkansas Arizona California Florida Georgia Indiana Louisiana Missouri Mississippi New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia

Questions about this recall

Why was it recalled?

Due to false positive results.

Which lots are affected?

Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817

Where was it sold?

U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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