MalfunctionJQT
AFINION AS100 ANALYZER US VERSION
Received Jun 30, 2026 · Event occurred Jun 5, 2026
Report 9613069-2026-00002 · MDR key 25664153
Device
Generic name
Analyzer
Manufacturer
Abbott Diagnostics Technologies AsModel number
1115175Catalog number
1115175
Lot number
10165736
Product problems
- Product Quality Problem
- Sparking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RETURN OF DEVICE INITIATED.
Description of Event or Problem
ON (B)(6) 2026: BIOMED PHONED TECHNICAL SERVICES (TS) TO REPORT AN AFINION INSTRUMENT AS100 ON BEHALF OF THE END USER AS IT WAS REPORTED TO THEM THAT THEIR AFINION ANALYZER SPARKED.
Remedial action
- Replace