Summary
The FDA issued a Class II for Matrix Clinical Solution At-Home COVID-19 Test by Matrix Medical Network. Reason: Due to COVID-19 Test not being authorized for home sample collection..
Details
Source
Device Recall
External ID
Z-0947-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Matrix Clinical Solution At-Home COVID-19 Test
Lot/Code Info: Product Number SKU: 15206 All Test Kits No Lot Numbers
Quantity Affected: 3,226 kits
Reason for Recall
Due to COVID-19 Test not being authorized for home sample collection.
Distribution
U.S.: AL, AZ, CA, CO, CT, DC, DE, FL, GA, LA, MA, MD, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, and WV. O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-24
Company
Scottsdale, AZ
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 150 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 (Matrix Medical Network) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Matrix Medical Network have FDA actions?
This is the only FDA action we have on record for Matrix Medical Network in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0947-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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