Respiratory Virus Panel Nucleic Acid Assay System

Reports per year

Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-05-29Open, ClassifiedUnder Investigation by firm

  BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

  Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

• 2025-04-15Open, ClassifiedProcess change control

  Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

  The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

• 2025-04-15Open, ClassifiedProcess change control

  Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

  the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

• 2024-10-09Open, ClassifiedDevice Design

  NxTAG Respiratory Pathogen Panel, REF: I051C0447

  Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

• 2024-09-11Open, ClassifiedUnder Investigation by firm

  FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

  Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

• 2023-03-03Open, ClassifiedDevice Design

  Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

  Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

• 2017-02-22TerminatedMixed-up of materials/components

  Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

  Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.

• 2016-07-13TerminatedIncorrect or no expiration date

  cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.

  Kit labeled with the incorrect expiration date.

• 2016-04-02TerminatedUnder Investigation by firm

  Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

  Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.

• 2015-09-02TerminatedNonconforming Material/Component

  cobas Liat Analyzer, for in vitro diagnostic use.

  Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.