Matrix Medical Network Matrix Clinical Solution At-Home COVID-19 Test Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to COVID-19 Test not being authorized for home sample collection.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AZ, CA, CO, CT, DE, FL, GA, LA, MD, MA, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WV, DC