medical Class I Updated 2022-03-09

CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, FL, NJ, NY, PA, SC
Lot/Code Info: Lot COVGCCM0008
View official government recall

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