FDA Medical Device Recalls (openFDA)
Matrix Medical Network: Matrix Clinical Solution At-Home COVID-19 Test
- Recall number
- Z-0947-2022
- Recalling firm
- Matrix Medical Network
- Product
- Matrix Clinical Solution At-Home COVID-19 Test
- Status
- Open, Classified
- Initiated
- 2022-01-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to COVID-19 Test not being authorized for home sample collection.
- 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: labsupport@matrixhealth.net - 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
- 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
- Lot, serial or model codes
- Product Number SKU: 15206 All Test Kits No Lot Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QLW
- Firm FEI
- 3021556946
- Firm city
- Scottsdale
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28