BD Leucocount™ 341003Recalls & reported problems
Becton, Dickinson And Company · BD Leucocount Combo RBC/PLT Control Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903410033), received between May 17, 2021 and Aug 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Contamination of Device Ingredient or Reagent1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER/ CONTAMINATION IN THE REAGENT DURING USE WITH THE BD LEUCOCOUNT¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER EACH THERMO CYCLE USE OF THE COMBO CONTROL, DEBRIS IS INCREASING, WHICH IS STARTING TO IMPACT THE BEAD COUNT. CUSTOMER WOULD LIKE TO INVESTIGATE THE ISSUE. BOX WAS OPENED LAST WEEK AND HAS GONE THROUGH 3 THERMAL CYCLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17477582 ↗MalfunctionMay 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE TESTING WITH BD LEUCOCOUNT¿ LOW RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOW RESULTS OBTAINED WITH RBC HIGH COMPARED TO EXPECTED VALUES. NOTICED AFTER USE. RESULTS OBTAINED WITH RBCH CONTROLS WERE LOWER THAN EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11834657 ↗
Other Counter, differential cell devices
- Cytomics FC500 UPS (CXP)Beckman Coulter, Inc. · Counter, Differential Cell1,196 reports
- CELL-DYN 08H67-01Abbott Laboratories · Counter, differential cell6 recalls269 reports
- Alinity 09P6801Abbott Laboratories · Counter, differential cell2 recalls96 reports
- FACSCanto 338960Becton, Dickinson And Company · Counter, differential cell1 recall117 reports
- Cytomics FC500 UPS (MPL)Beckman Coulter, Inc. · Counter, Differential Cell141 reports
- CELL-DYN 08H00-01Abbott Laboratories · Counter, differential cell1 recall90 reports
- CELL-DYN 09H39-01Abbott Laboratories · Counter, differential cell123 reports
- BD Multitest 662995Becton, Dickinson And Company · Counter, differential cell2 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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