Z-0659-2022 Class I Terminated
FDA device recall Z-0659-2022 was initiated by CELLTRION USA INC on Dec 28, 2021 and is designated Class I. 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. The recall status is terminated (terminated Jun 10, 2024). Affected quantity: 243 kits (6,075 tests).
Recall details
- Product Type
- Devices
- Report Date
- Mar 9, 2022
- Initiation Date
- Dec 28, 2021
- Termination Date
- Jun 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 243 kits (6,075 tests)
Product description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
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.
Distribution pattern
US distribution to CA, FL, NJ, NY, PA, SC.
Code information
Lot COVGCCM0008
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0659-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026