Z-0947-2022Class II

Matrix Clinical Solution At-Home COVID-19 Test

Name: Z-0947-2022 Matrix Clinical Solution At-Home COVID-19 Test
Creator: Matrix Medical Network
Published: 2022-01-24
License: https://open.fda.gov/license/

Matrix Medical Network / initiated 2022-01-24 / Open, Classified

FDA source

Matrix Medical Network began a recall of Matrix Clinical Solution At-Home COVID-19 Test on 2022-01-24. FDA classified it as Class II and gives the reason as "Due to COVID-19 Test not being authorized for home sample collection". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0947-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-24
Posted: 2022-04-15
Recalling firm: Matrix Medical Network
Product: Matrix Clinical Solution At-Home COVID-19 Test
Product code: QLW Covid-19 Test Home Collection Kit Devices
Reason for recall: Due to COVID-19 Test not being authorized for home sample collection.
FDA root cause: Other
Action: On 01/24/2022 and 03/16/2022, the firm contacted its customers via telephone to informing them that the recall, removal of unused test kits, is being initiated because it appears that sample collection was being conduct from a home setting. FDA has not authorized this test for at-home sample collection. On 03/18/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via US Postal to customer. Customers are being instructed to: 1. Immediately discard the product. 2. If product was used, it is recommended that the user of the product talk to their health care provider if there is any concern about their test results. 3. If the product was further distributed to another person, please notify them of this recall and share the recall letter with them 4. Complete and return the enclosed response form to the below address as soon as possible: - If returning it by email: [email protected] - If returning it by mail: Matrix Clinical Labs, 8161 Maple Lawn Blvd., Ste. 375 Fulton, MD 20759 For questions, call us at 1-855-362-5221. We are available Monday-Friday 8am-4pm EST.
Quantity in commerce: 3,226 kits
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
Product codes and lots: Product Number SKU: 15206 All Test Kits No Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0947-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0947-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-15

Product code QLW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)