xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Luminex Molecular Diagnostics
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Product Codes/Lot Numbers:
Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132
Distribution:
Distributed in: US, CA, CT, MA, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0161-2020
Related Recalls
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Luminex Molecular Diagnostics
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Luminex Molecular Diagnostics
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
Luminex Molecular Diagnostics
Reports have been received of lower MS2 MFI values when using the panel.