Immunohistochemistry Antibody Assay, Estrogen Receptor
Hematology · 21 CFR 864.1860
Recent MDR events
19 adverse event reports on file
- CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYApr 6, 2026InjuryVentana Medical Systems Inc.2028492-2026-01315
- CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYFeb 17, 2026MalfunctionVentana Medical Systems Inc.2028492-2026-00549
- CONFIRM ANTIESTROGEN RECEPTOR ER SP1 RABBIT MONOCLONAL PRIMARY ANTIBODYJan 23, 2026MalfunctionVentana Medical Systems, Inc.24162064
- CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYJan 12, 2026InjuryVentana Medical Systems Inc.2028492-2026-00138
- CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYDec 18, 2025InjuryVentana Medical Systems Inc.2028492-2025-05194
- CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYDec 18, 2025InjuryVentana Medical Systems Inc.2028492-2025-05193
- CONFIRM ANTI-ESTROGEN RECEPTOR ER SP1Jan 10, 2024MalfunctionVentana Medical Systems Inc.2028492-2024-00111
- ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿Jan 10, 2024InjuryLeica Biosystems Newcastle Ltd3004859032-2024-00001
- ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿Jan 10, 2024InjuryLeica Biosystems Newcastle Ltd3004859032-2024-00002
- ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿Nov 7, 2023InjuryLeica Biosystems Newcastle Ltd3004859032-2023-00001
Event type breakdown
Recalls
3 recall events for this product code
- Ventana Medical Systems IncTerminatedSep 14, 2018
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3007-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedJul 1, 2011
ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001)
The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number 760-091, lot B01057A.)
Z-2716-2011 · View FDA record ↗ - Ventana Medical Systems IncTerminatedJul 1, 2011
iView DAB Detection Kit, Part number: 760-091
The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number 760-091, lot B01057A.)
Z-2717-2011 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
Proteintech Group Inc
Rosemont, IL, US
Agilent Technologies, Inc.
CARPINTERIA, CA, US
Biogenex Laboratories Inc.
Fremont, CA, US
Agilent Technologies, Inc
Santa Clara, CA, US
Ventana Medical Systems, Inc.
Tucson, AZ, US
Biocare Medical, Llc
Pacheco, CA, US
Leica Biosystems Newcastle Ltd
NEWCASTLE UPON TYNE, GB
Agilent Technologies Inc.
Cedar Creek, TX, US
Richard-allan Scientific Llc
KALAMAZOO, MI, US
Microgenics Corporation
Fremont, CA, US
510(k) clearances
12 clearances for this product code
- Leica Biosystems Newcastle, LimitedDec 7, 2018
K183100 · Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
- Dako Denmark A/SDec 21, 2017
K170028 · FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
- Leica Biosystems Newcastle, Ltd.May 19, 2014
K122556 · VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- Dako North America, Inc.Feb 12, 2013
K120663 · MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
- Ventana Medical Systems, Inc.Dec 17, 2012
K110215 · CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
- Dako North America, Inc.May 8, 2009
K081286 · MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
- Lab Vision Corp.Jun 27, 2006
K061360 · NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
- Vision Biosystems, Inc.May 25, 2006
K060227 · VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)