QuickVue 20402Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,225 adverse event reports that list this exact device (DI 30014613339724), received between Aug 17, 2021 and Sep 15, 2025 — classified as 11 injuries, 4,214 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2,320 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 4,225 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONLINE CUSTOMER REVIEW REPORTS 2 FALSE POSITIVE RESULTS COMPARED TO OTHER RAPID TEST AND UNSPECIFIED PHYSICIAN TEST. FREQUENCY NOT PROVIDED. NOT SPECIFIED IF SYMPTOMATIC OR ASYMPTOMATIC. NO OTHER INFORMATION PROVIDED. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052775 ↗
• MalfunctionSep 15, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONLINE CUSTOMER REVIEW REPORTS 2 FALSE POSITIVE RESULTS COMPARED TO OTHER RAPID TEST AND UNSPECIFIED PHYSICIAN TEST. FREQUENCY NOT PROVIDED. NOT SPECIFIED IF SYPTOMATIC OR ASYMPTOMATIC. NO OTHER INFORMATION PROVIDED. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052774 ↗
• MalfunctionAug 11, 2025No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results

  CUSTOMER REPORTS CONFLICTING RESULTS USING EXPIRED TESTS. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774786 ↗
• MalfunctionJul 30, 2025No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results

  REPORTS CONFLICTING RESULTS RECIEVED OVER MULTIPLE TESTS, PATIENT HAD COLD-LIKE SYMPTOMS. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671479 ↗
• MalfunctionJun 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS FALSE POSITIVE RESULTS COMPARED TO OTHER RAPID TEST, FREQUENCY NOT PROVIDED. NOT SPECIFIED IF SYMPTOMATIC OR ASYMPTOMATIC. NO OTHER INFORMATION PROVIDED. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309476 ↗
• InjuryJan 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS BLOOD ON SWAB AFTER SAMPLE COLLECTION. NOTED DRY NOSE PRIOR TO SAMPLE COLLECTION. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140603 ↗
• MalfunctionJan 10, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED TWO FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131536 ↗
• MalfunctionJan 10, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED TWO FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131535 ↗
• MalfunctionJan 10, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED TWO FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131534 ↗
• MalfunctionJan 10, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED TWO FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131533 ↗
• MalfunctionJan 10, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED ONE ALLEGED FALSE POSITIVE SARS RESULT. NO CONFIRMATORY TESTING WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131532 ↗
• MalfunctionDec 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS FALSE POSITIVE TESTS CONFIRMED WITH PCR AND OTHER RAPID TEST. UNKNOWN NUMBER OF TESTS PERFORMED. CUSTOMER USING EXPIRED PRODUCT. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. REPORT 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21041621 ↗
• MalfunctionDec 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS FALSE POSITIVE TESTS CONFIRMED WITH PCR AND OTHER RAPID TEST. UNKNOWN NUMBER OF TESTS PERFORMED. CUSTOMER USING EXPIRED PRODUCT. UNKNOWN IF PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. REPORT 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21041597 ↗
• MalfunctionNov 27, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 5 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20792840 ↗
• MalfunctionNov 27, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 8 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20792184 ↗
• MalfunctionNov 27, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 6 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20791624 ↗
• MalfunctionNov 27, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 4 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20791529 ↗
• MalfunctionNov 27, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 9 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20790649 ↗
• MalfunctionNov 27, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 3 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20790563 ↗
• MalfunctionNov 26, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 1 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20789675 ↗
• MalfunctionNov 26, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 2 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20785479 ↗
• MalfunctionNov 26, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTS 9 FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. RESULTS INTERPRETED AFTER READ TIME. REPORT 7 OF 9.

  Patient problems: Insufficient Information

  MAUDE report 20784235 ↗
• MalfunctionNov 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. UNABLE TO PROVIDE EXACT NUMBER OF TESTS. REPORTING 2 MDRS FOR THIS LOT. REPORT 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 20750762 ↗
• MalfunctionNov 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS FALSE POSITIVES. UNKNOWN IF SYMPTOMATIC OR ASYMPTOMATIC. UNABLE TO PROVIDE EXACT NUMBER OF TESTS. REPORTING 2 MDRS FOR THIS LOT. REPORT 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 20750655 ↗
• InjuryOct 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REPORTS A LITTLE BLOOD PRESENT ON SWAB. PATIENT COMMUNICATED HAVING A DRY NOSE. NO APPARENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527758 ↗