Matrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection
Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device not authorized for its stated use method. An unvalidated at-home test could produce unreliable results with no reported illnesses to date, fitting the rubric criterion for High (3) severity.
Plain-English summary
The Matrix Clinical Solution At-Home COVID-19 Test is being recalled. This diagnostic test kit was distributed to consumers for at-home COVID-19 testing. A total of 3,226 test kits were distributed across multiple U.S. states.
The test was recalled because it was not authorized by the FDA for home sample collection. The FDA did not validate this product to ensure accurate results when samples are collected at home by consumers. The product was distributed without this required FDA authorization.
The affected test kits were distributed in Alabama, Arizona, California, Colorado, Connecticut, Washington D.C., Delaware, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, and West Virginia.
Consumers who received this product should not use the test kits.
The recalled product
- Product
- Matrix Clinical Solution At-Home COVID-19 Test
- Manufacturer
- Matrix Medical Network
- Category
- Medical Device — Diagnostic Test
- Affected units
- 3,226
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Number SKU: 15206 All Test Kits No Lot Numbers
Distribution
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