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Recall Observatory FDA recall evidence

Device product

xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

Z-0161-2020

July 16, 2019

Class II

Product summary

Firm
Luminex Molecular Diagnostics
Event
Event 83472
Status
Ongoing
Classification
Class II
Quantity
56 Kits
Official record key
device-enforcement:Z-0161-2020

Official wording

Reason: The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.

Code information: Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132

Distribution pattern: US distribution to CA, CT, MA, and PA OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.