Recall Z-3008-2018— Ventana Medical Systems Inc
Class I · Terminated
Class I FDA medical device recall by Ventana Medical Systems Inc, initiated 2018-08-02, terminated 2021-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.. Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers.
- Recalling firm
- Ventana Medical Systems Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-08-02
- Terminated
- 2021-11-22
- Firm location
- Oro Valley, AZ, United States
Product description
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
Data sourced from openFDA. This site is unofficial and independent of the FDA.