MalfunctionCGJ
ELECSYS FSH
Received Jan 8, 2026 · Event occurred Dec 18, 2025
Report 1823260-2026-00108 · MDR key 24005335
Device
Generic name
Radioimmunoassay, Follicle-stimulating Hormone
Manufacturer
Roche DiagnosticsCatalog number
11775863122
Lot number
62576501
Product problems
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CASE OF THE EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6) THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FSH ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS <0.300 MIU/ML. THE REPEAT RESULT WAS 6.80 MIU/ML.