Fully Automated Urine Particle Analyzer UF-5000 BN344411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987562440139), received between Jun 13, 2019 and Aug 10, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A USER IN THE (B)(6) REPORTED A URINE CULTURE WAS DELAYED DUE TO FALSE LOW WHITE BLOOD CELL (WBC) AND BACTERIA (BACT) RESULTS. THE SAMPLE WAS ANALYZED, AND LOW WBC AND BACT RESULTS WERE GENERATED. THE RESULTS WERE RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS). THE NEXT DAY, THE USER REPORTED WBC QUALITY CONTROL (QC) WAS RECOVERING LOW OUT OF RANGE. DURING INVESTIGATION, IT WAS FOUND THE UF-CELLPACK CR REAGENT HAD INADVERTENTLY BEEN EMPTIED AND FILLED WITH DEIONIZED WATER ON ALL ANALYZERS DURING WEEKLY MAINTENANCE. WEEKLY MAINTENANCE CONSISTS OF EMPTYING AND REPLENISHING THE RINSE WATER, AND THE RINSE WATER BOTTLE IS SIMILAR IN APPEARANCE TO THE UF-CELLPACK CR REAGENT. THE SAMPLE WAS REANALYZED ON A DIFFERENT ANALYZER AFTER THE UF-CELLPACK CR REAGENT WAS PROPERLY INSTALLED. THE ANALYZER GENERATED HIGHER WBC AND BACT RESULTS. NO PATIENT HARM WAS ALLEGED DUE TO THE CULTURE DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385348 ↗
• InjuryJan 31, 2020High Test Results; High Test Results

  AN OPERATOR IN DENMARK ALLEGED A CEREBROSPINAL FLUID (CSF) SAMPLE WAS ANALYZED AND GENERATED FALSELY ELEVATED POLYMORPHONUCLEAR LEUKOCYTES (PMN) AND FALSELY DECREASED MONONUCLEAR CELLS (MN). THERE WERE NO ERROR MESSAGES OR FLAGS WITH THE RESULTS. THESE RESULTS WERE NOT VERIFIED WITH MICROSCOPIC EVALUATION. DUE TO DUE TO THE PATIENT'S CLINICAL SIGNS AND SYMPTOMS AND RESULTS FROM THE CSF SAMPLE, THE PATIENT RECEIVED ANTIBIOTICS AND ANTI-VIRAL TREATMENT BEGINNING ON (B)(6) 2020. ADDITIONAL TESTS FOR BLOOD CULTURE AND CSF CULTURE WERE INITIATED. SIX DAYS LATER, ANOTHER CSF SAMPLE WAS COLLECTED AND ANALYZED, WHICH GENERATED LOWER PMN RESULTS AND HIGHER MN RESULTS AS COMPARED TO THE INITIAL CSF VALUES. THESE RESULTS WERE CONFIRMED BY MICROSCOPIC EVALUATION. ANTIBIOTIC TREATMENT WAS DISCONTINUED AND STEROID TREATMENT WAS STARTED BASED ON THE SECOND CSF SAMPLE RESULTS. NO PATIENT HARM WAS REPORTED BASED ON THE ADMINISTRATION OF ANTIBIOTIC TREATMENT, DELAY OF STEROID TREATMENT OR THE SECOND CSF COLLECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9655919 ↗
• MalfunctionJun 13, 2019Smoking; Smoking

  IN (B)(6), THE USER OF A SYSMEX UF-5000 AUTOMATED URINE PARTICLE ANALYZER WITH A CV-11, URINE SAMPLE TRANSPORTATION UNIT, SERIAL NUMBER (SN) (B)(4), REPORTED SPARKS, SMOKE AND A BURNING ODOR COMING FROM THE CV-11 FOLLOWING A SPILL FROM A RACK OF URINE SAMPLES. THE USER REPORTED THAT THE CV-11 HAD CEASED OPERATION UNEXPECTEDLY, PROMPTING A RE-INITIALIZATION. UPON RE-INITIALIZATION, THE SAMPLE RACK WAS PUSHED TOWARDS THE LEFT RACK POOL AREA THAT COLLECTS SAMPLES AFTER ANALYSIS AND TIPPED OVER, SPILLING THE URINE ONTO THE CONVEYOR. THE USER IMMEDIATELY CLEANED THE AREA, BUT WITHIN AN HOUR OF THE SPILL, THE USER NOTED SPARKS, SMOKE AND A BURNING ODOR COMING FROM THE CV-11. A FIRE EXTINGUISHER WAS DEPLOYED AT THE SOURCE OF THE SMOKE. THERE WERE NO REPORTS OF HARM TO THE USERS OR PATIENTS DUE TO THE EVENT. A NEW CV-11 WAS INSTALLED TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8697169 ↗