Z-0558-2022 Class II Terminated
FDA device recall Z-0558-2022 was initiated by CELLTRION USA INC on Dec 1, 2021 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 17, 2024). Affected quantity: 162,000 ea.
Recall details
- Product Type
- Devices
- Report Date
- Feb 9, 2022
- Initiation Date
- Dec 1, 2021
- Termination Date
- Jun 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162,000 ea
Product description
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.
Reason for recall
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 pattern
US Nationwide distribution in the state of CA.
Code information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0558-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026