Reported Feb 10, 2021 · Terminated

SARS-CoV-2 Antigen Test

Qiagen Sciences LLC

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: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415

Is this the product you have?

  • SARS-CoV-2 Antigen Test
Lot codes and dates
  • GTIN
    • 04053228039785
    • Catalog #: 646533
    • Lot #: 86651
    • 86652
    • 86653
    • 86654
    • 86659
Amount recalled
1092 boxes of 60 (65,520 e-sticks)

Where it was sold

Why it was recalled

QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

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 Jul 11, 2022 · Data as of Sep 19, 7:00 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.