RecallRadar

FDA Device recall Z-0731-2022

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

On 2022-03-16 the FDA classified a Class II recall of Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 by Celltrion Usa, citing kits were labeled with incorrect expiration dates.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0731-2022
ClassificationClass II
Statusongoing
Initiated2022-02-25
Published2022-03-16
Last updated2026-09-13 11:56 UTC
CompanyCelltrion Usa
DistributionCA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, TX

Product

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

Reason

Kits were labeled with incorrect expiration dates.

Identifiers

code_infoLot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0731-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.