Ventana Medical Systems Inc recalls INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in v…
- Recall date
- August 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3014-2018
- FDA classification
- Class I
- Brand / firm
- Ventana Medical Systems Inc
- Sold / distributed
- worldwide
Why it was recalled
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
Get recall alerts
Free email alert whenever Ventana Medical Systems Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Ventana Medical Systems Inc