Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall #Z-0659-2022 — Class I — December 28, 2021
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for Recall
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.
Recalling Firm
CELLTRION USA INC — Jersey City, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
243 kits (6,075 tests)
Distribution
US distribution to CA, FL, NJ, NY, PA, SC.
Code Information
Lot COVGCCM0008
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated