FDAFDA · Food and drugs·Recall number Z-3014-2018
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
Published September 26, 2018 · Recall initiated: August 2, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventana Medical Systems Inc
- Distributor
- worldwide
- Lot
- Lot Number: Y19417, UDI: 4015630972210
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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