Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reported: March 9, 2022 Initiated: December 28, 2021 #Z-0659-2022
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.
Details
- Recalling Firm
- CELLTRION USA INC
- Units Affected
- 243 kits (6,075 tests)
- Distribution
- US distribution to CA, FL, NJ, NY, PA, SC.
- Location
- Jersey City, NJ
Frequently Asked Questions
What product was recalled? ▼
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02. Recalled by CELLTRION USA INC. Units affected: 243 kits (6,075 tests).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Critical. Recall number: Z-0659-2022.
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