ARIES® Flu A/B & RSV Assay 50-10020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840487100158), received between Jan 15, 2021 and Jan 26, 2021 — classified as 2 deaths.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 26, 2021Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED INFLUENZA B POSITIVE ON ARIES FLU A/B AND RSV ASSAY. ARIES: INFLUENZA B POSITIVE SAMPLE WAS NOT REPEATED ON ANOTHER PLATFORM, THERE IS NO DISCREPANCY TO REPORT. ON 1/22/2021 LUMINEX WAS MADE AWARE THAT THERE WAS A PATIENT DEATH INVOLVED THE PATIENT TESTED POSITIVE FOR BOTH COVID AND FLU B, THE FLU B WAS RESULTED FROM THE ARIES ASSAY. THE PATIENT WAS ADMITTED DUE TO FATIGUE, SOB, COUGH, CHILLS, NAUSEA, HYPOXIA. THE ARIES FLU B RESULT WAS RELEASED TO THE PHYSICIAN ON (B)(6) 2021 @ 2055. THE PATIENT ALSO TESTED POSITIVE FOR COVID OFF-SITE A WEEK PRIOR (APPROX. (B)(6) 2020). CUSTOMER DID NOT KNOW WHICH PLATFORM WAS USED FOR COVID TESTING OR WHICH GENES WERE DETECTED. THE PATIENT WAS RECEIVING FOLLOWING THE TREATMENTS PRIOR TO ARIES RESULT, CEFTRIAXONE AND DOXYCYCLINE ((B)(6) 2021), REMDESIVIR ((B)(6) 2021), AZITHROMYCIN; THE ADDITION OF TAMIFLU WAS ADDED ((B)(6) 2021) AFTER THE ARIES RESULT WAS RELEASED.

  Patient problems: Chills; Cough; Death; Dyspnea; Fatigue; Hypoxia; Nausea; Test Result

  MAUDE report 11231005 ↗
• DeathJan 15, 2021Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED A DISCREPANCY RESULTS FOR INFLUENZA B ON ARIES FLU A/B AND RSV ASSAY. ARIES: INFLUENZA B POSITIVE. SAMPLE WAS NOT REPEATED ON ARIES. CONFIRMATION TESTING, (B)(6) PUBLIC HEALTH LAB PCR STATE (MULTIPLEX RT PCR): INFLUENZA B NEGATIVE. THE PATIENT WAS ADMITTED DUE TO FEVER, CHILLS, SOB, WEAKNESS, HYPOTENSION, PNEUMONIA, SEPSIS. THE ARIES FLU B RESULT WAS RELEASED TO THE PHYSICIAN ON (B)(6) 2020 @ 1959. THE PATIENT WAS RECEIVING FOLLOWING THE TREATMENTS PRIOR TO ARIES RESULT, AZITHROMYCIN, VANCOMYCIN, ZOSYN; THE ADDITION OF TAMIFLU WAS ADDED AFTER THE ARIES RESULT WAS RELEASED. THE SAMPLE WAS NOT STORED BEFORE TESTING ON THE ARIES. THIS PATIENT'S SAMPLE CAME TO THE LABORATORY FROM THE EMERGENCY DEPARTMENT AND WAS TESTED IMMEDIATELY ON DEMAND (IT WAS ORDERED STAT). ON (B)(6) 2020, SAMPLE RAN ON ARIES (B)(4) MODULE A POSITION A4 RUN: ARIESK1-RUN#493-A SAMPLE ID (B)(6) RESULT: INFLUENZA A NEGATIVE, RSV NEGATIVE, INFLUENZA B POSITIVE (CT= 39.4 TM= 78.6). THE SAMPLE WAS STORED REFRIGERATED PRIOR TO TESTING AT (B)(6) PUBLIC HEALTH LAB AND RESULTED AS A FLU B NEGATIVE. QC WAS RAN ON THE ARIES INSTRUMENT 9 HOURS PRIOR ON A4 AND WAS SUCCESSFUL. DATE/TIME OF EXPIRY: (B)(6) 2020

  Patient problems: Death; Dyspnea; Fever; Low Blood Pressure/ Hypotension; Pneumonia; Sepsis; Weakness

  MAUDE report 11181405 ↗