NEO IRIS
Received Apr 30, 2026
Report 1034569-2026-00014 · MDR key 25046557
Device
Generic name
Automated Blood Bank System
Manufacturer
Immucor, Inc.Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A REVIEW OF QUARTERLY EVENTS INDICATED FOURTEEN (14) EVENTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.
Additional Manufacturer Narrative
NO COMMON SPECIFIC ROOT CAUSE OR DEFECT WAS IDENTIFIED. THE CONCLUSION(S) CODE(S) REPORTED HEREIN ARE ASSIGNED ACCORDING TO THE FACTS PRESENTED BY THE AFFECTED CUSTOMER AND IMMUCOR'S ASSESSMENT AND INVESTIGATION OF THOSE FACTS. WHEN POSSIBLE, IMMUCOR ATTEMPTS TO OBTAIN THE ACTUAL SAMPLES AND REAGENTS INVOLVED; RETENTION REAGENTS OF THE SAME LOT THAT WAS INVOLVED IN THE EVENT MAY BE USED DURING THE INVESTIGATION IF INDICATED. ALSO, WHEN POSSIBLE, IMMUCOR USES REMOTE ACCESS TO REVIEW THE RELEVANT DATA ARCHIVED ON THE INSTRUMENT. THE EVENTS REPORTED ON THIS QUARTERLY MALFUNCTION SUMMARY REPORT ARE LIMITED TO THOSE IN WHICH NO PATIENT HARM OCCURRED, AND NO DESIGN DEFECT (OR OTHER SYSTEMIC PROBLEM) WAS IDENTIFIED. THERE IS NO SPECIFIC ACTION THAT USERS ARE EXPECTED TO TAKE TO MITIGATE THE REPORTED DEVICE FAILURE/MALFUNCTION OTHER THAN TO ENSURE THAT PREVENTATIVE MAINTENANCE IS PERFORMED AS INDICATED IN THE INSTRUMENT INSTRUCTIONS. IMMUCOR WILL CONTINUE TO TRACK AND TREND PERFORMANCE AND OPERATIONAL ISSUES SUCH AS DESCRIBED IN THIS QUARTERLY MALFUNCTION SUMMARY REPORT.