inforMED
MalfunctionSCA

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

Unknown

Catalog 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.