Reported Feb 20, 2013 · Terminated

Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

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 Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Lot codes and dates
  • Lot #
  • Range
    • 208228-214385
    • 707916-708108 (29 lots)
Amount recalled
13,090 kits (327,250 tests)

Where it was sold

  • Nationwide

Why it was recalled

Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.

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 Jan 31, 2014 · Data as of Sep 19, 5:30 PM UTC

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