Jersey City, NJ, United States
CELLTRION USA INC recalls
5 recalls recorded since 2018, most recently on 1 April 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)3
Terminated Class I Medical devices
- Recall started
- 1 April 2022
- Terminated
- 11 June 2024
- Reason
- Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0953-2022
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Ongoing Class II Medical devices
- Recall started
- 25 February 2022
- Reason
- Kits were labeled with incorrect expiration dates.
- Distribution
- The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0731-2022
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Terminated Class I Medical devices
- Recall started
- 28 December 2021
- Terminated
- 10 June 2024
- Reason
- 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.
- Distribution
- US distribution to CA, FL, NJ, NY, PA, SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0659-2022
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Terminated Class I Medical devices
- Recall started
- 2 December 2021
- Terminated
- 10 June 2024
- Reason
- Returned 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.
- Distribution
- Distributed to TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0680-2022
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Terminated Class II Medical devices
- Recall started
- 1 December 2021
- Terminated
- 17 June 2024
- Reason
- The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0558-2022
- Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.