FDAFDA · Food and drugs·Recall number Z-3010-2018
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 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 Numbers: Y12986, Y16448, Y24119, Y16912Z, UDI: 4015630970018
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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