Lyra Coronavirus (REF M120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 30014613339090), received between Apr 20, 2021 and Mar 20, 2025 — classified as 86 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (73 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  REPORTED ONE FALSE POSITIVE SARS RESULTS FOR ONE SYMPTOMATIC PATIENT. UNKNOWN IF THE RESULT WAS CONFIRMED. CONFIRMATION METHOD(S) NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654465 ↗
• MalfunctionMar 13, 2025False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  FALSE POSITIVE RATE OF 36% WITH NO DETAILS REGARDING THE EXACT NUMBER OF INDIVIDUAL PATIENT EVENTS. NO CONFIRMATORY TESTING COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596853 ↗
• MalfunctionNov 9, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 3 SARS RESULTS REPORTING AS POSITIVE DUE TO HIGH BACKGROUND NOISE (POTENTIAL FALSE POSITIVE RESULTS). NO CONFIRMATION TESTING WAS PERFORMED. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104127 ↗
• MalfunctionNov 9, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 3 SARS RESULTS REPORTING AS POSITIVE DUE TO HIGH BACKGROUND NOISE (POTENTIAL FALSE POSITIVE RESULTS). NO CONFIRMATION TESTING WAS PERFORMED. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103933 ↗
• MalfunctionNov 9, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 3 SARS RESULTS REPORTING AS POSITIVE DUE TO HIGH BACKGROUND NOISE (POTENTIAL FALSE POSITIVE RESULTS). NO CONFIRMATION TESTING WAS PERFORMED. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103923 ↗
• MalfunctionSep 28, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 3 SUSPECTED FALSE POSITIVE SARS RESULTS. NO CONFIRMATION TESTING WAS PERFORMED ON THE SAMPLES AND DURING INTERVIEW WITH THE CUSTOMER IT WAS FOUND THEY WERE USING AN UNAPPROVED EXTRACTION SYSTEM AS WELL AS AN OFF-LABEL TRANSPORT MEDIA. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840733 ↗
• MalfunctionSep 28, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 3 SUSPECTED FALSE POSITIVE SARS RESULTS. NO CONFIRMATION TESTING WAS PERFORMED ON THE SAMPLES AND DURING INTERVIEW WITH THE CUSTOMER IT WAS FOUND THEY WERE USING AN UNAPPROVED EXTRACTION SYSTEM AS WELL AS AN OFF-LABEL TRANSPORT MEDIA. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840732 ↗
• MalfunctionSep 28, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING 3 SUSPECTED FALSE POSITIVE SARS RESULTS. NO CONFIRMATION TESTING WAS PERFORMED ON THE SAMPLES AND DURING INTERVIEW WITH THE CUSTOMER IT WAS FOUND THEY WERE USING AN UNAPPROVED EXTRACTION SYSTEM AS WELL AS AN OFF-LABEL TRANSPORT MEDIA. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840731 ↗
• MalfunctionJul 20, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT WITH AN ATYPICAL CURVE. SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN OR IF ADDITIONAL METHODS WERE RUN. IT IS NOTED THE SAMPLE IS COLLECTED OFFSITE AND PLACED INTO VIRAL TRANSPORT MEDIA (VTM) SOLUTION PRIOR TO TESTING (OFF LABEL USAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070732 ↗
• MalfunctionJul 11, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  CUSTOMER REPORTING FALSE POSITIVE SARS RESULT WITH A CT VALUE OF 28. CUSTOMER STATED THE SAMPLE WAS NEGATIVE BY ANOTHER LABORATORY TEST. SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN. ATTEMPTS WERE MADE TO GATHER FURTHER INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978817 ↗
• 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 14887254 ↗
• 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 14887245 ↗
• 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 14887223 ↗
• 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 14887196 ↗
• 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 14887179 ↗
• 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 14887156 ↗
• 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 14887099 ↗
• 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 14887093 ↗
• MalfunctionJun 30, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  THE CUSTOMER REPORTED A HIGH NUMBER OF FALSE POSITIVE RESULTS DUE TO SUSPECTED CONTAMINATION. THE EXACT NUMBER IS UNKNOWN AND MOST OF THE RESULTS WERE NOT LIKELY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880908 ↗
• MalfunctionJun 30, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 1 FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE SAMPLE RESULTED POSITIVE BY 2 OTHER MOLECULAR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880490 ↗
• MalfunctionJun 30, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 1 FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE SAMPLE RESULTED POSITIVE BY 2 OTHER MOLECULAR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880487 ↗
• MalfunctionJun 30, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 1 FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE SAMPLE RESULTED POSITIVE BY 2 OTHER MOLECULAR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880477 ↗
• MalfunctionJun 30, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 1 FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE SAMPLE RESULTED POSITIVE BY 2 OTHER MOLECULAR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880476 ↗
• MalfunctionJun 30, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 1 FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE SAMPLE RESULTED POSITIVE BY 2 OTHER MOLECULAR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880422 ↗
• MalfunctionJun 30, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  CUSTOMER REPORTING 1 FALSE NEGATIVE SARS RESULT. CUSTOMER COMMUNICATED THE SAMPLE RESULTED POSITIVE BY 2 OTHER MOLECULAR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880295 ↗