Z-0953-2022 Class I Terminated
FDA device recall Z-0953-2022 was initiated by CELLTRION USA INC on Apr 1, 2022 and is designated Class I. Reason for recall: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. The recall status is terminated (terminated Jun 11, 2024). Affected quantity: 12,632 kits.
Recall details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- Apr 1, 2022
- Termination Date
- Jun 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,632 kits
Product description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Distribution pattern
US Nationwide distribution.
Code information
All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0953-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026