CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Company
- Ventana Medical Systems Inc
- Recall Initiated
- August 2, 2018
- Posted
- September 14, 2018
- Terminated
- November 22, 2021
- Recall Number
- Z-3007-2018
- Quantity
- 1719 units
- Firm Location
- Oro Valley, AZ
Reason for Recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Distribution
worldwide
Lot / Code Info
Lot Numbers: Y18586, Y24472, UDI: 4015630972234
Root Cause
Under Investigation by firm
Action Taken
The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
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