FDAFDA · Food and drugs·Recall number Z-0953-2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Published May 4, 2022 · Recall initiated: April 1, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CELLTRION USA INC
- Distributor
- US Nationwide distribution.
- Lot
- All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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