MicroScan B1018-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590690885), received between Jun 2, 2020 and Feb 13, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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.

Recalls naming this device

1. 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-1085-2022 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathFeb 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING HIGH PROBABILITY MISIDENTIFICATION (HPID) OF CITROBACTER FARMERI ON PATIENT SAMPLES USING NEG URINE COMBO 90 (NUC90, P/N C48640, LOT # 2025-11-11) PANELS PROCESSED IN THEIR DXM 1040 MICROSCAN WALKAWAY INSTRUMENT S/N (B)(6). THE CUSTOMER STATED THE MISIDENTIFICATION IMPACTED ONE PATIENT SAMPLE, MULTIPLE CULTURES. THE CUSTOMER NOTIFIED THE PHYSICIAN OF THE ERRONEOUS RESULTS OBTAINED FROM URINE SAMPLE. THE CUSTOMER STATED THE PATIENT WAS PUT ON HOSPICE AND PASSED AWAY ON (B)(6) 2025. IT WAS FURTHER NOTED THAT THE PATIENT DID NOT HAVE CAPACITY AND WAS REFUSING TREATMENT. THE PATIENT¿S FAMILY OPTED FOR COMFORT FOCUSED MEASURES. THE CUSTOMER INDICATED THEY REACHED OUT TO THEIR INTERNAL TEAM, AND THEY STATED THE MISIDENTIFICATION CAUSED A DELAY IN APPROPRIATE TREATMENT FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381586 ↗
• MalfunctionJun 2, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING THE UNPACKING OF THE DXM 1040 WALKAWAY INSTRUMENT, THE COUNTERWEIGHT, COUNTER WEIGHT ROD AND VERTICAL AXIS READ ASSEMBLY SLIPPED CAUSING A NEAR INJURY TO THE FSE DUE TO A MISSING SHAFT LOCK CLIP. THE FSE WAS NOT INJURED AS THE PACKAGING MATERIAL CAUGHT THE COUNTERWEIGHT AFTER ONLY 1-INCH SLIP.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement; Not Applicable

  MAUDE report 10111548 ↗