Recall Z-3007-2018— 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. It names one FDA 510(k) clearance: K110215. Product: CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.. Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur..
- 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Data sourced from openFDA. This site is unofficial and independent of the FDA.