Reported Feb 9, 2022 · Terminated
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer,…
Celltrion USA Inc.
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: 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, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
- Lot codes and dates
- All lots
- Amount recalled
- 162,000 ea
Where it was sold
- Nationwide
- CA
Why it was recalled
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
This product could cause temporary or reversible health problems — stop using it.
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