MalfunctionJJE
ELISA ANALYZER (EUROIMMUN)
Received Feb 26, 2026
Report MW5184490 · MDR key 24461545
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Euroimmun Medizinische Labordiagnostika AgModel number
DS-EIA-HBSAG-0.01Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING ROUTINE LABORATORY TESTING, THE HBSAG TEST PRODUCED FALSE POSITIVE AND FALSE NEGATIVE RESULTS. THE RESULTS WERE INCONSISTENT WITH CLINICAL FINDINGS AND CONFIRMATORY TESTING. REPEAT TESTING, QUALITY CONTROL CHECKS, AND TROUBLE SHOOTING WERE PERFORMED; HOWEVER, THE ISSUE PERSISTED. THIS INDICATES A PRODUCT PERFORMANCE PROBLEM THAT MAY AFFECT THE ACCURACY AND RELIABILITY OF PATIENT RESULTS AND POSES A POTENTIAL RISK OF MISDIAGNOSIS. RPC - DIAGNOSTIC SYSTEMS, LTD.