Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0659-2022 — Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

U.S. FDA — Device Enforcement · United States · 2021-12-28 · Class I

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0659-2022
Date of alert
2021-12-28
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
CELLTRION USA INC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.