Home › Device types › GKZ
Counter, Differential Cell
FDA product code GKZ · Class 2 · Hematology
442
Registered devices
23,449
Adverse events
244
Recalls
381
510(k) clearances
Devices with this code
Lymphotype HLA-DR/DQ 72 — Bio-Rad Medical Diagnostics GmbHQBC Diagnostics — DRUCKER DIAGNOSTICSCS/CC MsIgG2a-RD1 — Beckman Coulter, Inc.ADAMII-CD34 Kit — NanoEnTek, Inc.Simultest — Becton, Dickinson And CompanyABX PENTRA DX 120 — HORIBA ABX SASCS/CC T8-FITC — Beckman Coulter, Inc.QBC Diagnostics — DRUCKER DIAGNOSTICSAthelas One — Athelas, Inc.CS/CC MsIgG1-RD1/ MsIgG1-FITC — Beckman Coulter, Inc.Medonic M-series — Boule Medical ABCS/CC CD3(IgG1)-FITC/T8-RD1 — Beckman Coulter, Inc.Automated Hematology Analyzer XE-2100D — SYSMEX CORPORATIONQBC Diagnostics — DRUCKER DIAGNOSTICSQBC Diagnostics — DRUCKER DIAGNOSTICSCS/CC MsIgM-RD1 — Beckman Coulter, Inc.QwikCheck Test Strips — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.CS triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5 — Beckman Coulter, Inc.CS triCHROME CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 — Beckman Coulter, Inc.COULTER LH — Beckman Coulter, Inc.QBC Diagnostics — DRUCKER DIAGNOSTICSHemoScreen — PIXCELL MEDICAL TECHNOLOGIES LTDFACSDiva — BECTON, DICKINSON AND COMPANYFlowCARE PLG CD4 Reagent — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-18 | Abbott Laboratories | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect r |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou |
| 2025-07-08 | Becton, Dickinson and Company, BD Bio Sciences | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. |
| 2025-07-08 | Becton, Dickinson and Company, BD Bio Sciences | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. |
| 2025-06-03 | Becton, Dickinson and Company, BD Bio Sciences | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior |
| 2025-06-03 | Becton, Dickinson and Company, BD Bio Sciences | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior |
| 2025-03-18 | Abbott Laboratories | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expir |
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