ABBOTT AFINION 2
Received Mar 24, 2026 · Event occurred Feb 18, 2026
Report 9613069-2026-00001 · MDR key 24672281
Device
Generic name
Analyzer
Manufacturer
Abbott Diagnostics Technologies AsModel number
1116682Catalog number
1116682
Lot number
10202599
Product problems
- Failure to Power Up
- Smoking
- Unexpected Shutdown
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS INITIATED AND ON-GOING. INSTRUMENT REPLACEMENT ALSO INITIATED.
Description of Event or Problem
ON THE 27FEB2026 ABBOTT ACCOUNT MANAGER SENT EMAIL TO TECHNICAL SERVICE TS REPORTING THAT THEY THEIR CUSTOMER HAS ISSUES ON THEIR TWO AFINION 2 INSTRUMENTS AS FOLLOWS: SERIAL NUMBER SN # (B)(6) DOES NOT PERFORM THE TEST, INFORMATION CODE 213 SERIAL NUMBER SN # (B)(6) JUST STOPPED WORKING AND STARTED TO SMELL LIKE IT WOULD START TO BURN. THIS EVENT IS FOR SN # (B)(6). ON 02MAR2026 THE CUSTOMER CONFIRMED THE FOLLOWING FOR SN # (B)(6). - THE INCIDENT OCCURRED ON FEBRUARY 18, 2026. - NO PATIENTS WERE INVOLVED. - SMOKE APPEARED AND THERE WAS A BURNING SMELL. - THE INSTRUMENT WAS NOT HOT, AND NO STAFF WERE INJURED.
Remedial action
- Replace