Reported May 4, 2022 · Terminated

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Celltrion USA Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: CELLTRION USA INC · 1 Evertrust Plz Ste 1207 · Jersey City, NJ · 07302-3087

Is this the product you have?

    • Celltrion DiaTrust COVID-19 Ag Rapid Test
    • Reference No. CT-P60 D-2 02
Lot codes and dates
  • All lots distributed
  • to end users without valid CLIA ID UPC8 806121 763044 Distributed from December 2021 through February 2022
Amount recalled
12,632 kits

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 11, 2024 · Data as of Sep 19, 5:40 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.