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CELLTRION USA INC Recall 89516

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

CELLTRION USA INC Recall 89516 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0680-2022
Event ID89516
Event DescriptionCelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Product TypeDevices
DistributionDistributed to TX.
Quantity8080 kits originally distributed; 726 kits redistributed
Recall ReasonReturned 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.
Device Classification20220309
Device Code InfoLots COVGCCF0001, COVGCCF0002
Center Classification Date20220302
Recall Initiation Date20211202
Recalling FirmCELLTRION USA INC
Initial Notification E-Mail
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