Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Summary
The FDA issued a Class I for Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 by CELLTRION USA INC. Reason: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID..
Details
Source
Device Recall
External ID
Z-0953-2022
Action Date
2022-05-04
Status
Terminated
Category
device
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Lot/Code Info: All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
Quantity Affected: 12,632 kits
Reason for Recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
Company
Jersey City, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CELLTRION USA INC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CELLTRION USA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CELLTRION USA INC have FDA actions?
CELLTRION USA INC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0953-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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