Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Celltrion DiaTrust COVID-19 Ag Rapid Test Recalled by CELLTRION USA INC Due to Point of Care (PoC) rapid test products were...

Date: April 1, 2022
Company: CELLTRION USA INC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CELLTRION USA INC directly.

Affected Products

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

Quantity: 12,632 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CELLTRION USA INC

CELLTRION USA INC has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report