Reported Nov 18, 2020 · Terminated

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Quidel Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Quidel Corporation · 10165 McKellar Ct · San Diego, CA · 92121-4201

Is this the product you have?

  • QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Lot codes and dates
  • Model Number 20374 Lot Number706142
  • UPC A GTIN-120 14613 33908 2
  • Cassettes168365 through 166817
Amount recalled
8,628 kits

Where it was sold

Why it was recalled

Due to false positive results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 18, 2024 · Data as of Sep 19, 5:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.