Luminex xTAG Respiratory Viral Panel Recalled for False Negative Results
Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device that may produce false negative results for specific respiratory viruses, creating a risk of misdiagnosis or delayed treatment, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Luminex Molecular Diagnostics is recalling 56 kits of the xTAG Respiratory Viral Panel (RVP), Catalogue Number I019C0111. The affected lots are IK019C-0129, IK019C-0130, IK019C-0131, and IK019C-0132. These in vitro diagnostic test kits were distributed in the United States to California, Connecticut, Massachusetts, and Pennsylvania.
The recall was initiated because the assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. The source text notes that the assay will continue to detect Influenza A, Influenza B, RSV B, and all other targets in accordance with the product's performance claims.
Healthcare facilities and laboratories that possess these specific lots should stop using the kits and contact Luminex Molecular Diagnostics for instructions on return or replacement.
The recalled product
- Product
- xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
- Manufacturer
- Luminex Molecular Diagnostics
- Affected units
- 56
Distribution
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