Reported Oct 30, 2019 · Ongoing
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro…
Luminex Molecular Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Molecular Diagnostics · 439 University Ave Suite 900 · Toronto · N/A
Is this the product you have?
- xTAG Respiratory Viral Panel (RVP)Box
- LabelxTAG RVP (Respiratory Viral Panel)
- Catalogue NumberI019C0111 in vitro diagnostic test
- Lot codes and dates
- Catalogue NumberI019C0111
- Device UDI00840487100462
- Lot NumbersIK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132
- Amount recalled
- 56 Kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Luminex Molecular Diagnostics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.