FDA recall Z-0161-2020

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2019-07-16

Report date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0161-2020