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Respiratory Pathogens Flex (RP Flex) Extraction Tray

NANOSPHERE, INC. · Model 20-009-024 · UDI-DI 00857573006263

510(k) clearances

Adverse events

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
2026-02-09	Abbott Diagnostics Scarborough, Inc.	It was confirmed that the impacted lot has 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.
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.
2024-04-26	Centers For Disease Control and Prevention	The H5b component may fail to amplify, resulting in an inconclusive result.
2019-02-20	Luminex Corporation	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially

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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.