CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
Received Apr 6, 2026 · Event occurred Mar 17, 2026
Report 2028492-2026-01315 · MDR key 24794327
Device
Generic name
Estrogen (oestrogen)/progesterone Receptor Ivd, Antibody
Manufacturer
Ventana Medical Systems Inc.Catalog number
05278406001
Lot number
M25411
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE BENCHMARK ULTRA INSTRUMENT IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING ALLEGED DISCREPANT FALSE NEGATIVE CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY RESULTS FOR PATIENT SAMPLES TESTED ON A BENCHMARK ULTRA INSTRUMENT. THE INITIAL RESULT WAS REPORTEDLY NEGATIVE. THE REPEAT RESULT WAS REPORTED TO BE MODERATELY POSITIVE. REPORTEDLY, IT WAS INDICATED THAT ONE PATIENT WILL LIKELY NEED STEROIDS FOR THE REST OF THEIR LIFE, AFTER THE TREATMENT THEY RECEIVED. FURTHER INFORMATION WAS REQUESTED. THERE ARE NO REPORTS ABOUT THE DETERIORATION OF THE PATIENT'S HEALTH.