MalfunctionMYA

CONFIRM ANTIESTROGEN RECEPTOR ER SP1 RABBIT MONOCLONAL PRIMARY ANTIBODY

Received Jan 23, 2026 · Event occurred Nov 21, 2025

Report 24162064 · MDR key 24162064

Device

Generic name

Immunohistochemistry Antibody Assay, Estrogen Receptor

Manufacturer

Ventana Medical Systems, Inc.

Model number

250 TESTS

Catalog number

05278414001

Lot number

M18867

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE LAB AT [REDACTED] RECENTLY LEARNED OF A ROCHE CUSTOMER BULLETIN ACKNOWLEDGING SUBPAR STAINING FOR SPECIFIC LOTS USED IN ER IHC [ESTROGEN RECEPTOR] TESTING. SEE THE ATTACHED BULLETIN. THE BULLETIN RECOMMENDS THAT LABS DISCARD ANY OF THE AFFECTED LOTS BUT DOES NOT EXPLICITLY RECOMMEND THAT IMPACTED PATIENT SAMPLES BE RE-TESTED.