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: Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to .
Details
Source
Device Recall
External ID
Z-0680-2022
Action Date
2022-03-09
Status
Terminated
Category
device
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Lot/Code Info: Lots COVGCCF0001, COVGCCF0002
Quantity Affected: 8080 kits originally distributed; 726 kits redistributed
Reason for Recall
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Distribution
Distributed to TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-02
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 130 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-0680-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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