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CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Recalled March 9, 2022 · FDA recall Z-0659-2022 · CELLTRION USA
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. · FDA Class I
Units
243 kits (6,075 tests)
Sold at
US distribution to CA, FL, NJ, NY, PA, SC.
Description
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.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Manufacturer(s)
CELLTRION USA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →