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Recall Observatory FDA recall evidence

Device product

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

Z-0731-2022

February 25, 2022

Class II

Product summary

Firm
CELLTRION USA INC
Event
Event 89640
Status
Ongoing
Classification
Class II
Quantity
1,228,200 tests
Official record key
device-enforcement:Z-0731-2022

Official wording

Reason: Kits were labeled with incorrect expiration dates.

Code information: Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007

Distribution pattern: The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits were labeled with incorrect expiration dates.