LyraRecalls & reported problems across all models

We found 2 models of Lyra by Diagnostic Hybrids, Inc. in the FDA's device registry (GUDID). Together they are named in 489 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2021 and Mar 20, 2025 — classified as 489 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (388 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Lyra problems

Lyra models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Lyra Coronavirus

  Reagents, 2019-novel coronavirus nucleic acid
  403 reports
• Lyra Coronavirus

  Reagents, 2019-novel coronavirus nucleic acid
  86 reports

Recent Lyra adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗