Lyra Coronavirus (REF M124)Recalls & reported problems

Summary

The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 30014613339144), received between Apr 20, 2021 and Dec 16, 2022 — classified as 403 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (315 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 403 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING AN ABNORMALLY HIGH SARS POSITIVITY RATE ON ONE INSTRUMENT VS THE OTHER. CUSTOMER STATES THEY TESTED THE SAME PATIENT PLATE ON BOTH INSTRUMENTS. THE INSTRUMENT IN QUESTION PRODUCED 25 POSITIVE SARS RESULTS WHILE THE OTHER PRODUCED 2 POSITIVE SARS RESULTS. PATIENTS ARE BOTH SYMPTOMATIC AND ASYMPTOMATIC. IT IS NOTED THAT SERVICING OF THE INSTRUMENT WAS PERFORMED RECENTLY. REPORT 23 OF 23 DISCORDANT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000881 ↗
• MalfunctionSep 29, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING FALSE POSITIVE SARS RESULT. CUSTOMER STATES THE RESULT WAS CONFIRMED NEGATIVE BY ANOTHER MOLECULAR METHOD. IT IS NOTED THE CUSTOMER STARTED EXPERIENCING ISSUES AFTER A 3RD PARTY PIECE OF EQUIPMENT WAS REPLACED AND IS ALSO HAVING THE NEGATIVE QC CONTROL RESULT POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507083 ↗
• MalfunctionSep 29, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 4 FALSE POSITIVE SARS RESULTS. CUSTOMER STATES THE RESULTS WERE CONFIRMED NEGATIVE BY ANOTHER MOLECULAR METHOD. IT IS NOTED THE CUSTOMER STARTED EXPERIENCING ISSUES AFTER A 3RD PARTY PIECE OF EQUIPMENT WAS REPLACED AND IS ALSO HAVING THE NEGATIVE QC CONTROL RESULT POSITIVE. REPORT 3 OF 4

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506722 ↗
• MalfunctionSep 29, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 4 FALSE POSITIVE SARS RESULTS. CUSTOMER STATES THE RESULTS WERE CONFIRMED NEGATIVE BY ANOTHER MOLECULAR METHOD. IT IS NOTED THE CUSTOMER STARTED EXPERIENCING ISSUES AFTER A 3RD PARTY PIECE OF EQUIPMENT WAS REPLACED AND IS ALSO HAVING THE NEGATIVE QC CONTROL RESULT POSITIVE. REPORT 2 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506656 ↗
• MalfunctionSep 29, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 4 FALSE POSITIVE SARS RESULTS. CUSTOMER STATES THE RESULTS WERE CONFIRMED NEGATIVE BY ANOTHER MOLECULAR METHOD. IT IS NOTED THE CUSTOMER STARTED EXPERIENCING ISSUES AFTER A 3RD PARTY PIECE OF EQUIPMENT WAS REPLACED AND IS ALSO HAVING THE NEGATIVE QC CONTROL RESULT POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506645 ↗
• MalfunctionSep 29, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 4 FALSE POSITIVE SARS RESULTS. CUSTOMER STATES THE RESULTS WERE CONFIRMED NEGATIVE BY ANOTHER MOLECULAR METHOD. IT IS NOTED THE CUSTOMER STARTED EXPERIENCING ISSUES AFTER A 3RD PARTY PIECE OF EQUIPMENT WAS REPLACED AND IS ALSO HAVING THE NEGATIVE QC CONTROL RESULT POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506543 ↗
• MalfunctionJul 27, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING A FALSE POSITIVE SARS RESULT WITH A SAMPLE SHOWING AN ATYPICAL CURVE. THE CUSTOMER COMMUNICATED THE RETEST OF THE SAMPLE IS NEGATIVE AND THE NEGATIVE RESULT WAS SUBMITTED. MOST PATIENTS WERE ASYMPTOMATIC AS THEY WERE TESTED FOR PRE-OP SCREENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117376 ↗
• MalfunctionJul 8, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE OBSERVED LOW POSITIVE SPECIMEN WAS CONFIRMED POSITIVE BY CDC METHOD. IT IS NOTED THE CUSTOMER IS USING AN OFF-LABEL, SELF-VALIDATED METHOD FOR TESTING SINGLE SAMPLE COLLECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959832 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887242 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887217 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887193 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887189 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887188 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887186 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887180 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887176 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887170 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887168 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887165 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887163 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887159 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887149 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887148 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887144 ↗
• MalfunctionJul 1, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER RULED OUT ENVIRONMENTAL CONTAMINATION SOURCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887141 ↗