CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall Z-3007-2018 · Posted 2018-09-14
Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeMYA
Date Initiated2018-08-02
Date Terminated2021-11-22
Product Quantity1719 units
Reason for Recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Firm Action
The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
Root Cause
Under Investigation by firm
Distribution Pattern
worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.