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
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