CVS Health At Home COVID-19 Test Kit 20452Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30014613340188), received between Nov 8, 2024 and Jun 25, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CONSUMER REPORTS 2 FALSE NEGATIVE RESULTS. CUSTOMER ADMITS TO USING EXPIRED PRODUCT. PATIENT SYMPTOMATIC. UNCONFIRMED BY ALTERNATE TEST METHOD. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331040 ↗
• MalfunctionJun 25, 2025False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CONSUMER REPORTS 2 FALSE NEGATIVE RESULTS. CUSTOMER ADMITS TO USING EXPIRED PRODUCT. PATIENT SYMPTOMATIC. UNCONFIRMED BY ALTERNATE TEST METHOD. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331039 ↗
• MalfunctionJan 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 2 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENTS SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21220342 ↗
• MalfunctionJan 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 2 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENTS SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21220341 ↗
• MalfunctionJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 6 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENT SYMPTOMATIC WITH SORE THROAT. NO APPARENT ADVERSE EVENT. REPORT 6 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143358 ↗
• MalfunctionJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 6 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENT SYMPTOMATIC WITH SORE THROAT. NO APPARENT ADVERSE EVENT. REPORT 5 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143357 ↗
• MalfunctionJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 6 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENT ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143353 ↗
• MalfunctionJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 6 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENT ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 3 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143352 ↗
• MalfunctionJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 6 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENT SYMPTOMATIC WITH SORE THROAT. NO APPARENT ADVERSE EVENT. REPORT 4 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143351 ↗
• MalfunctionJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS 6 FALSE POSITIVE RESULTS COMPARTED TO OTHER RAPID ANTIGEN TEST. PATIENT ASYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143348 ↗
• InjuryJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS PLACING SWAB INTO LIQUID REAGENT, THEN INTO NOSE FOR SAMPLE COLLECTION. CUSTOMER STATES THEY DID NOT HAVE ANY IRRITATION AND FELT FINE. NO APPARENT ADVERSE EVENT. CUSTOMER DIRECTED TO POISON CONTROL CONTACT INFORMATION IN USER INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139477 ↗
• MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  CONSUMER REPORTED INCONSISTENT RESULTS. NO CONFIRMATORY TESTING PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895969 ↗
• MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  CONSUMER REPORTED INCONSISTENT RESULTS. NO CONFIRMATORY TESTING PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895384 ↗
• InjuryNov 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  CONSUMER CAME IN CONTACT WITH REAGENT SOLUTION AND CONTACTED POISON CONTROL. NO OTHER INFORMATION WAS PROVIDED. CUSTOMER WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698246 ↗
• MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  CONSUMER REPORTED POSSIBLE INVALID RESULT. ONCE CUSTOMER SPOKE TO TECHNICAL SUPPORT AND HAD THE RESULTS EXPLAINED TO THEM, THEY UNDERSTOOD THAT THE RESULTS WERE VALID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642305 ↗
• MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  CONSUMER REPORTED POSSIBLE INVALID RESULT. ONCE CUSTOMER SPOKE TO TECHNICAL SUPPORT AND HAD THE RESULTS EXPLAINED TO THEM, THEY UNDERSTOOD THAT THE RESULTS WERE VALID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642198 ↗