Medical device recalls High risk

CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Recall date
April 1, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0953-2022
FDA classification
Class I
Brand / firm
CELLTRION USA INC
Sold / distributed
US Nationwide distribution.

Why it was recalled

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Get recall alerts

Free email alert whenever CELLTRION USA INC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: CELLTRION USA INC