MicroScan B1018-496Recalls & reported problems
Beckman Coulter, Inc. · DxM 1096 MicroScan Walkaway Instrument · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590690892), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 21, 2019Open, Classified
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1086-2022 · Root cause: Mixed-up of materials/components · FDA record ↗
Most reported problems
Device problems
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
THE CUSTOMER REPORTED THE GENERATION OF HIGH PROBABILITY MISIDENTIFICATION RESULTS USING B1017-219 PC45 PANELS PROCESSED ON THEIR WALKAWAY (WA) SYSTEM (S/N: (B)(6). THE CUSTOMER STATED THAT A PATIENT ISOLATE WAS INITIALLY IDENTIFIED AS S. SHOLIFERI (BIOTYPE 313731, 99.99% PROBABILITY) USING PC45 PANEL, AND THIS IDENTIFICATION WAS REPORTED TO THE PHYSICIAN. REPEAT TESTING USING BIOFIRE AND B1017-166 RPID2 PANEL WAS PERFORMED, AND BOTH GAVE AN IDENTIFICATION OF S. AUREUS. THE UPDATED IDENTIFICATION REPORT WAS PROVIDED TO THE PHYSICIAN, AND THE PHYSICIAN HAD TO CHANGE THE PATIENT'S COURSE OF TREATMENT BASED ON THE AMENDED REPORT WITH THE CORRECT ORGANISM IDENTIFICATION, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.
Patient problems: Insufficient Information
MAUDE report 20364584 ↗
Other Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems devices
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- MicroScan B1018-440Beckman Coulter, Inc. · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems1 recall1 death2 reports
- Thermo Scientific™ Sensititre™ ARIS HiQ™ System V4000Trek Diagnostic Systems Limited · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.