Walgreens 505288Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00311917122045), received between Jun 30, 2023 and Oct 16, 2024 — classified as 2 injuries, 97 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (51 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CONSUMER REPORTED ONE FALSE POSITIVE SARS RESULT. THE CONSUMER COMMUNICATED THE RESULT WAS CONFIRMED BY ALTERNATE TESTING METHOD (METHOD UNKNOWN). THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466487 ↗
• MalfunctionOct 16, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CONSUMER REPORTED ONE FALSE POSITIVE SARS RESULT. THE CONSUMER COMMUNICATED THE RESULT WAS CONFIRMED BY ALTERNATE TESTING METHOD (METHOD UNKNOWN). THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465179 ↗
• MalfunctionOct 15, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED THREE FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY MOLECULAR (PCR TESTING). THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457316 ↗
• MalfunctionOct 15, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED THREE FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY MOLECULAR (PCR TESTING). THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457280 ↗
• MalfunctionOct 15, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED THREE FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY MOLECULAR (PCR TESTING). THIS IS REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457237 ↗
• MalfunctionSep 25, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED TWO FALSE POSITIVE SARS RESULTS. THE CONSUMER REPORTED THE RESULT WAS CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THE REPORT WAS OBTAINED FROM AN ONLINE CONSUMER REVIEW, NO FURTHER INFORMATION COULD BE OBTAINED AS NO CUSTOMER CONTACT WAS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300687 ↗
• MalfunctionSep 24, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED TWO FALSE POSITIVE SARS RESULTS. THE CONSUMER REPORTED THE RESULT WAS CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY THE REPORT WAS OBTAINED FROM AN ONLINE CONSUMER REVIEW, NO FURTHER INFORMATION COULD BE OBTAINED AS NO CUSTOMER CONTACT WAS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295787 ↗
• MalfunctionSep 19, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTED ONE FALSE POSITIVE SARS RESULT. UNKNOWN IF THE RESULT WAS CONFIRMED. CONFIRMATION METHOD(S) NOT PROVIDED.THE REPORT WAS OBTAINED FROM AN ONLINE CONSUMER REVIEW; NO FURTHER INFORMATION COULD BE OBTAINED AS NO CUSTOMER CONTACT WAS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263210 ↗
• MalfunctionSep 17, 2024False 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 20239641 ↗
• MalfunctionSep 17, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  REPORTED TWO FALSE NEGATIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY AN ALTERNATE TESTING METHOD (METHOD UNKNOWN). THIS IS REPORT 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 20239612 ↗
• MalfunctionSep 17, 2024False 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 20239538 ↗
• MalfunctionSep 17, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  REPORTED TWO FALSE NEGATIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY AN ALTERNATE TESTING METHOD (METHOD UNKNOWN). THIS IS REPORT 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 20239533 ↗
• MalfunctionSep 13, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED ONE FALSE NEGATIVE SARS RESULT. THE CONSUMER COMMUNICATED IT WAS CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215483 ↗
• MalfunctionSep 10, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED FOUR FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 4 OF 4.

  Patient problems: Sore Throat

  MAUDE report 20184173 ↗
• MalfunctionSep 10, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED FOUR FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 1 OF 4.

  Patient problems: Sore Throat

  MAUDE report 20184110 ↗
• MalfunctionSep 10, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED FOUR FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 2 OF 4.

  Patient problems: Sore Throat

  MAUDE report 20184061 ↗
• MalfunctionSep 10, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED FOUR FALSE POSITIVE SARS RESULTS. THE CONSUMER COMMUNICATED THE RESULTS WERE CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. THIS IS REPORT 3 OF 4.

  Patient problems: Sore Throat

  MAUDE report 20184044 ↗
• MalfunctionSep 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  REPORTED ONE FALSE POSITIVE SARS RESULT. THE CONSUMER COMMUNICATED THE RESULT WAS CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY. CONSUMER WAS MILDLY SYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183885 ↗
• MalfunctionSep 9, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTED ONE FALSE NEGATIVE SARS RESULT. THE CONSUMER COMMUNICATED THE RESULT WAS CONFIRMED POSITIVE AT THE EMERGENCY ROOM THE FOLLOWING MORNING (METHOD UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176729 ↗
• MalfunctionSep 5, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 2 FALSE NEGATIVE SARS RESULTS. CUSTOMER STATES THEIR RESULTS WERE POSITIVE BY ANOTHER BRAND RAPID ANTIGEN AND AN ER TEST (METHOD UNKNOWN). REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151092 ↗
• MalfunctionSep 5, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 2 FALSE NEGATIVE SARS RESULTS. CUSTOMER STATES THEIR RESULTS WERE POSITIVE BY ANOTHER BRAND RAPID ANTIGEN AND AN ER TEST (METHOD UNKNOWN). REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150884 ↗
• MalfunctionAug 26, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING CONSISTENTLY TESTING POSITIVE ON THIS TEST BUT NEGATIVE ON OTHER BRAND OF RAPID ANTIGEN TEST. CUSTOMER IS SYMPTOMATIC WITH COUGH, CONGESTION AND CHEST PAIN DUE TO COUGHING. TIMEFRAME BETWEEN TESTING OF DIFFERENT BRANDS IS UNKNOWN. NO CONFIRMATION TESTING WAS PERFORMED. CUSTOMER IS NOT SURE HOW MANY POSITIVE TESTS THEY HAD. TWO REPORTS WILL BE FILED FOR UNKNOWN NUMBER OF POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066197 ↗
• MalfunctionAug 26, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING CONSISTENTLY TESTING POSITIVE ON THIS TEST BUT NEGATIVE ON OTHER BRAND OF RAPID ANTIGEN TEST. CUSTOMER IS SYMPTOMATIC WITH COUGH, CONGESTION AND CHEST PAIN DUE TO COUGHING. TIMEFRAME BETWEEN TESTING OF DIFFERENT BRANDS IS UNKNOWN. NO CONFIRMATION TESTING WAS PERFORMED. CUSTOMER IS NOT SURE HOW MANY POSITIVE TESTS THEY HAD. TWO REPORTS WILL BE FILED FOR UNKNOWN NUMBER OF POSITIVE RESULTS. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066196 ↗
• MalfunctionAug 21, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING TESTING NEGATIVE ON THIS ASSAY BUT POSITIVE ON ANOTHER BRAND RAPID ANTIGEN TEST. UNKNOWN IF CONFIRMATION TESTING WAS PERFORMED. FURTHER CONTACT WITH THE CUSTOMER IS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013441 ↗
• MalfunctionAug 21, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 2 FALSE NEGATIVE SARS RESULTS. CUSTOMER STATES THEY HAD A KNOWN COVID EXPOSURE AND THAT BOTH THEM AND THEIR CHILD STARTED DEVELOPING SYMPTOMS. CUSTOMER STATES THEY BOTH WERE NEGATIVE BY THIS TEST BUT POSITIVE BY ANOTHER BRAND RAPID ANTIGEN TEST (TIMEFRAME BETWEEN TESTING IS UNKNOWN AND FURTHER CONTACT WITH THE CUSTOMER IS NOT POSSIBLE). REPORT 2 OF 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012456 ↗