FDA-Device2022-03-09Class I
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
Hazard
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Sold states
US distribution to CA, FL, NJ, NY, PA, SC.
Affected count
243 kits (6,075 tests)
Manufactured in
1 Evertrust Plz Ste 1207, Jersey City, NJ, United States
Products
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0659-2022Don't want to check this manually?
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