Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA device recall Z-0659-2022 · posted 2022-03-02 · Terminated
Recall details
- Recalling firm
- CELLTRION USA INC
- 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.
- Action taken
- The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot.
- Root cause
- Process control
- Status
- Terminated
- Product code
- QKP
- Quantity affected
- 243 kits (6,075 tests)
- Distribution
- US distribution to CA, FL, NJ, NY, PA, SC.
- Date initiated
- 2021-12-28
- Date posted
- 2022-03-02
- Date terminated
- 2024-06-10
- Location
- Jersey City, NJ
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