Recall Z-0735-2018— Ventana Medical Systems Inc
Class I · Terminated
Class I FDA medical device recall by Ventana Medical Systems Inc, initiated 2017-12-19, terminated 2021-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic. Reason: Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II..
- Recalling firm
- Ventana Medical Systems Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-12-19
- Terminated
- 2021-11-22
- Firm location
- Oro Valley, AZ, United States
Product description
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Reason for recall
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Data sourced from openFDA. This site is unofficial and independent of the FDA.