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U.S. Department of Health and Human Services

Class 2 Device Recall Matrix Clinical Solution AtHome COVID19 Test

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  Class 2 Device Recall Matrix Clinical Solution AtHome COVID19 Test see related information
Date Initiated by Firm January 24, 2022
Create Date April 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0947-2022
Recall Event ID 89511
Product Classification COVID-19 test home collection kit devices - Product Code QLW
Product Matrix Clinical Solution At-Home COVID-19 Test
Code Information Product Number SKU: 15206 All Test Kits No Lot Numbers
Recalling Firm/
Manufacturer		 Matrix Medical Network
9201 E Mountain View Rd
Scottsdale AZ 85258-5199
For Additional Information Contact Laura Vivian
855-362-5221
Manufacturer Reason
for Recall		 Due to COVID-19 Test not being authorized for home sample collection.
FDA Determined
Cause 2		 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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