Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Summary
The FDA issued a Class II for Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "dec by Cellex. Reason: The kit does not have an emergency use authorization (EUA)..
Details
Source
Device Recall
External ID
Z-2452-2021
Action Date
2021-09-22
Status
Ongoing
Category
device
Product Description
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Lot/Code Info: All lot numbers
Quantity Affected: Approximately 44,821 kits
Reason for Recall
The kit does not have an emergency use authorization (EUA).
Distribution
US Nationwide distribution in the states of CA, FL, TX, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-01
Company
Morrisville, NC
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 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Cellex) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cellex have FDA actions?
This is the only FDA action we have on record for Cellex in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2452-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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