Reported Mar 9, 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 TestReference No. CT-P60 D-2 02
- Lot codes and dates
Lots COVGCCF0001COVGCCF0002
- Amount recalled
- 8080 kits originally distributed; 726 kits redistributed
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Using this product could cause serious injury, illness or death — stop using it now.
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