Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

BD Leucocount

Model 662418 · Becton, Dickinson And Company · DI 00382906624185

JPK — Mixture, Hematology Quality Control · Class II · 21 CFR 864.8625

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222020-10: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device10031107
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1001
2021-0302
2021-1101
2023-0701
This device (reports/month)Average device in JPK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Becton, Dickinson And Company

  • Warning Letter 2018-01-11 Becton Dickinson & Company
  • Warning Letter 2009-05-11 Becton Dickinson & Company
  • NAI 2026-04-16 Becton Dickinson and Co. · 0 citations
  • NAI 2026-04-16 Becton Dickinson and Co. · 0 citations
  • NAI 2025-08-01 Becton Dickinson & Co. · 0 citations
  • NAI 2024-05-21 Becton Dickinson Infusion Therapy Systems, Inc. · 0 citations
  • VAI 2024-05-02 BECTON, DICKINSON AND CO. · 3 citations
  • VAI 2024-05-02 BECTON, DICKINSON AND CO. · 3 citations
  • NAI 2024-02-29 Becton Dickinson Industrias Cirurgicas, LTDA. · 0 citations
  • NAI 2023-09-15 Becton Dickinson and Company · 0 citations
  • NAI 2023-09-15 Becton, DIckinson and Company · 0 citations
  • NAI 2023-09-15 Becton, DIckinson and Company · 0 citations
  • NAI 2023-09-15 Becton Dickinson and Company · 0 citations
  • VAI 2023-08-02 BD Medical · 0 citations
  • NAI 2023-03-23 Becton, Dickinson and Company · 0 citations
  • NAI 2023-03-23 Becton, Dickinson and Company · 0 citations
  • NAI 2023-01-11 Becton Dickinson and Co. · 0 citations
  • NAI 2023-01-11 Becton Dickinson and Co. · 0 citations
  • NAI 2022-12-15 Becton Dickinson Industrias Cirurgicas, LTDA. · 0 citations
  • VAI 2021-11-23 BD Puerto Rico LLC · 0 citations
  • NAI 2021-07-29 Becton Dickinson Caribe LTD · 0 citations
  • VAI 2021-07-23 Becton Dickinson & Co. · 1 citations