Respiratory Virus Panel Nucleic Acid Assay System

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.

Brand Name: ID NOW RSV 24T

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

Brand Name: ID NOW RSV 24T

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

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.

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.

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.

Influenza Transport Swab Packages, Reference #20171,

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

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

Kit labeled with the incorrect expiration date.

Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (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.

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.