CVS HEALTH COMBO COVID-19 & FLU A/B ANTIGEN TEST (ITEM #641986)
Received Sep 25, 2025 · Event occurred Sep 18, 2025
Report MW5176629 · MDR key 23149236
Device
Generic name
Multi-analyte Respiratory Virus Antigen Detection Test
Manufacturer
UnknownCatalog number
641986
Lot number
2503319DEN
Product problems
- Defective Device
Patient
59 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
USING CVS HEALTH COMBO COVID-19 & FLU A/B TEST; 2 TESTS IN PACKAGE. PURCHASED AT LOCAL CVS STORE BACK IN JUNE, AND USED ONE OF THE TWO TESTS THEN - NO ISSUE. ATTEMPTED TO USE SECOND TEST AND FOUND THAT THE "EXTRACTION TUBE TIP" WAS SOLID. THERE WAS NO HOLE OR PATH THROUGH IT TO ALLOW DROPS OF COLLECTED SAMPLE TO BE DEPOSITED ON THE TEST CASSETTE. I TRIED NOTIFYING BOTH STORE AND CVS PHONE NUMBER IN PACKAGE ABOUT DEFECT BUT THEY ONLY WERE CONCERNED ABOUT WHETHER I WAS SEEKING A REFUND. THEY DIDN'T WANT ANY OTHER INFO LIKE LOT OR OTHER DATA. PACKAGING GIVES AN ITEM NUMBER OF 641986, AND VISUALLY MATCHES SAME ITEM NUMBER AT CVS WEBSITE: HTTPS://WWW.CVS.COM/SHOP/CVS-HEALTH-COMBO-COVID-19-FLU-A-B-ANTIGEN-TEST-2-CT-PRODID-641986 LOT NUMBER FROM PACKAGE WITH DEFECTIVE PART 2503319DEN I DID USE ANOTHER COVID TEST I HAD FROM THE USPS DISTRIBUTION. AFTER FOLLOWING THE INSTRUCTIONS FOR THAT TEST, I TESTED POSITIVE FOR COVID AND AM SEEKING TREATMENT. UNABLE TO COMPLETE TEST DUE TO DEFECTIVE PART.