CELLTRION USA INC 2022-05-04 Health critical FDA
Health · FDA · Recall #FDA-Z-0953-2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Recall
Issued May 4, 2022 · CELLTRION USA INC
In May 2022, CELLTRION USA INC recalled the Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
What you should do
- 1 Stop using Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CELLTRION USA INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CELLTRION USA INC
- Category
- Health
- Recall date
- May 4, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0953-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- CELLTRION USA INC has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.