MicroScan B1018-284Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590658687), received between Aug 8, 2019 and Nov 6, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 FDA recall records 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-1084-2022 · Root cause: Mixed-up of materials/components · FDA record ↗

2. Sep 4, 2019Terminated

   Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

   Z-1371-2021 · Root cause: Process control · 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.

• InjuryNov 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED ISSUES WITH LOW PROBABILITY IDENTIFICATIONS AND (B)(6) RESISTANT MISREADS WHEN COMPARED TO VISUAL READ. CUSTOMER INDICATED THEY HAD TWO SPECIMENS WHERE ERRONEOUS RESULTS WERE REPORTED. FIRST SPECIMEN REPORTED AS (B)(6). UPON REPEAT, THE ISOLATE IDENTIFIED AS (B)(6). THE (B)(6) RESULT WAS REPORTED OUT AND QUESTIONED. THE PATIENT HAD A SPECIMEN RUN SEVERAL DAYS PRIOR THAT RESULTED AS (B)(6). THE (B)(6) RESULT WAS OBTAINED ON (B)(6) 2019. PHYSICIAN BEGAN (B)(6) TREATMENT FOR THE (B)(6) YEARS OLD FEMALE DIAGNOSED WITH SEPTIC SHOCK. AFTER THE REPEAT RESULT OF (B)(6) WAS OBTAINED ON (B)(6) 2019, THE CUSTOMER INDICATED THE TREATMENT WAS GOING TO BE CHANGED TO (B)(6). SECOND SPECIMEN WAS VERY RESISTANT AND TESTED AS ESCHERICHIA COLI ESBL NEGATIVE ON (B)(6) 2019. UPON REPEAT ON (B)(6) 2019, THE ORGANISM TESTED AS ESBL NEGATIVE AGAIN BUT WAS MANUALLY EDITED TO POSITIVE BASED ON VISUAL READ OF THE PANEL. THE PATIENT WAS A (B)(6) YEARS OLD MALE WITH A URINARY TRACT INFECTION. CUSTOMER DID NOT KNOW WHAT THE INITIAL TREATMENT WAS; THE AMENDED TREATMENT WAS MEROPENEM. THERE WAS A THIRD SPECIMEN HOWEVER NO ERRONEOUS RESULTS WERE REPORTED. THE ISOLATE TESTED AS KLEBSIELLA OXYTOCA

  Patient problems: Septic Shock; Urinary Tract Infection

  MAUDE report 9287658 ↗
• InjuryAug 8, 2019Device Handling Problem; Device Handling Problem

  WHILE ONSITE ON (B)(6) 2018 CONDUCTING A REPAIR ON WALKAWAY (WA) 96 PLUS, SERIAL NUMBER (B)(4), THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) INJURED HIS SHOULDER.

  Patient problems: Injury

  MAUDE report 8876535 ↗