BD Leucocount™ 340523Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903405237), received between May 28, 2021 and Jun 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING THE BD LEUCOCOUNT¿ THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRORS HAVE CREPT INTO THE NEW EIFU, BOTH IN THE ENGLISH VERSION AND PROBABLY IN ALL TRANSLATIONS (AT LEAST THE GERMAN ONE). IN THE MANUAL INSTRUMENT SETUP AS WELL AS IN THE MEASUREMENT OF THE DATA ON THE CALIBUR IT IS REFERRED TO THAT ONE SHOULD USE THE BD FACSCOMP SOFTWARE. THIS IS NOT CORRECT. THE BD FACSCOMP SOFTWARE CANNOT DO THIS, RATHER THE BD CELLQUEST PRO SOFTWARE IS USED FOR THIS. (THIS IS AN ERROR THAT WAS ALREADY PARTIALLY PRESENT IN THE OLD TECHNICAL DATASHEET AND HAS PROBABLY NOT BEEN IMPROVED). PAGE 8 TO PERFORM MANUAL SETUP USING BD FACSCOMP¿ SOFTWARE: (MUST BE BD CELLQUEST PRO SOFTWARE). PAGE 9 TO ACQUIRE THE SAMPLES USING BD FACSCOMP¿ SOFTWARE: (MUST BE BD CELLQUEST PRO SOFTWARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172509 ↗
• MalfunctionJul 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD LEUCOCOUNT¿ THERE WERE UNEXPECTED RESULTS. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER ENCOUNTERED TWO UNEXPECTED RESULTS (SAMPLE ID: (B)(6) AND (B)(6)) AS WELL AS THE IQC (LKR0521H). STAINING PROTOCOL: 400 L OF BD LEUCOCOUNT REAGENT [LOT 0294545 EXPIRY DATE 31/03/22] + 100L OF OUR SAMPLE IN A BD TRUCOUNT TUBE [LOT N°20276, 48 600 BEADS, EXPIRY DATE 31/10/22].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193696 ↗
• MalfunctionMay 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING PATIENT SAMPLES WITH BD LEUCOCOUNT¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 3RD OF MAY THEIR INTERNAL QC IS NOT PASSING EITHER (LEUCKOREDCED RBC&PL LOT 0521 FROM EUROCELL). THE LOT NUMBER OF THE LEUCOCOUNT REAGENT USED IS 1050800. THE RESULTS ORIGINALLY OBTAINED BY THE CUSTOMER ON HER FACSVIA R656874590153 BY USING OUR LEUCOUNT KIT WERE ERRONEOUS SINCE THE RWBC CONTROL WAS NOT IN THE EXPECTED RANGE: THIS WAS DUE TO THE FACT THAT THE WBC POPULATION WAS DISAPPEARING, THUS GENERATING AN ERRONEOUS CELL COUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904804 ↗
• MalfunctionMay 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE RUNNING PATIENT SAMPLES WITH BD LEUCOCOUNT¿ ERRONEOUS RESULTS OBTAINED WHEN RUNNING ON FACSVIA 590153, HOWEVER, RUNNING SAME SAMPLES ON FACSCALIBUR DIDN'T GENERATE THE ISSUE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEUCOCOUNT HUMAN REAGENT KIT 50TST IVD - CHANGE IN POPULATIONS IN THE PLOTS 2850854 340523_1029004 - LEUCOCOUNT HUMAN REAGENT KIT 50TST IVD - CHANGE IN POPULATIONS IN THE PLOTS. CUSTOMER STATES SHE ENCOUNTERED ISSUES WITH THEIR FACSVIA 590153 USING THE LEUCOCOUNT KIT ON THE 7TH OF APRIL. HOWEVER, RUNNING THE EXACT SAME SAMPLE WITH THE EXACT SAME KIT LOT ON THEIR FACSCALIBUR DIDN¿T GENERATE ISSUE. THEY WERE ABLE TO GENERATE THE DATA PROPERLY WITH THE FACSCALIBUR. THEY OPENED A NEW KIT LOT 1029004 ON THE 22ND OF APRIL, FOR WHICH THEY DID NOT EXPERIENCE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904712 ↗