MalfunctionLOJ
ELECSYS AFP
Received Jun 10, 2026 · Event occurred May 18, 2026
Report 1823260-2026-02293 · MDR key 25460645
Device
Generic name
Alpha-fetoprotein Test Kit
Manufacturer
Roche DiagnosticsCatalog number
09015060190
Lot number
86687201
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS AFP RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 0.908 NG/ML WITH A DATA FLAG. THE CUSTOMER REPEATED THE SAMPLE, AS THIS RESULT WAS LOWER THAN THE PREVIOUS RESULT FOR THE PATIENT. THE REPEAT RESULT WAS 3.26 NG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.