FDA recall Z-0659-2022

CELLTRION USA INC · Class I · device

Product

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

US distribution to CA, FL, NJ, NY, PA, SC.

Key facts

Status: Terminated
Initiation date: 2021-12-28
Report date: 2022-03-09
Termination date: 2024-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jersey City, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0659-2022