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Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge

LUMINEX CORPORATION · Model 20-006-024 · UDI-DI 00840487101612

OCC OZE OZZ OEM OOU OEP Prescription

510(k) clearances

808

Adverse events (9 deaths)

Recalls

Facilities

Description

The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.

Recalls

Date	Firm	Reason
2025-04-30	BioFire Diagnostics, LLC	Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
2025-03-04	Abbott Diagnostics Scarborough, Inc.	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Abbott Diagnostics Scarborough, Inc.	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2024-09-05	Luminex Molecular Diagnostics Inc	Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified pred
2024-08-07	BioFire Diagnostics, LLC	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
2023-01-30	DiaSorin Molecular LLC	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.
2020-10-30	Luminex Corporation	Potential for a false-negative result.
2020-10-30	Luminex Corporation	Potential for a false-negative result.
2020-10-30	Luminex Corporation	Potential for a false-negative result.
2020-10-30	Luminex Corporation	Potential for a false-negative result.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.