Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Summary
The FDA issued a Class II for Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 by CELLTRION USA INC. Reason: Kits were labeled with incorrect expiration dates..
Details
Source
Device Recall
External ID
Z-0731-2022
Action Date
2022-03-16
Status
Ongoing
Category
device
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Lot/Code Info: Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007
Quantity Affected: 1,228,200 tests
Reason for Recall
Kits were labeled with incorrect expiration dates.
Distribution
The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-25
Company
Jersey City, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0731-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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