Home › Device types › GKZ
Counter, Differential Cell
FDA product code GKZ · Class 2 · Hematology
439
Registered devices
23,439
Adverse events
244
Recalls
380
510(k) clearances
Devices with this code
CELL-DYN — ABBOTT LABORATORIESQBC Diagnostics — DRUCKER DIAGNOSTICSSimultest — Becton, Dickinson And CompanyCOULTER EPICS — Beckman Coulter, Inc.QBC Diagnostics — DRUCKER DIAGNOSTICSCS/CC CD3(IgG1)-FITC — Beckman Coulter, Inc.HemoScreen — PIXCELL MEDICAL TECHNOLOGIES LTDDxH 500 — BECKMAN COULTER IRELAND INC.ABX MICROS ES60 CT — HORIBA ABX SASBD Leucocount™ — BECTON, DICKINSON AND COMPANYQBC Diagnostics — DRUCKER DIAGNOSTICSABACUS 3CP Hematology Analyzer — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagFlowCARE PLG CD4 Reagent — Beckman Coulter, Inc.Human CD3 TRI-COLOR® Conjugate — LIFE TECHNOLOGIES CORPORATIONCC T4-FITC (CD4-FITC) — Beckman Coulter, Inc.QBC Diagnostics — DRUCKER DIAGNOSTICSQBC Diagnostics — DRUCKER DIAGNOSTICSAutomated Digital Morphology Analyzer DI-60 — Cellavision ABCELL-DYN — ABBOTT LABORATORIESFACSCanto — Becton, Dickinson And CompanyCYTO-COMP CELL KIT — Beckman Coulter, Inc.Automated Hematology Analyzer XN-L series XN-330 — SYSMEX CORPORATIONCS/CC MsIgG1-RD1/ MsIgG2a-FITC — Beckman Coulter, Inc.CS/CC MsIgG2b-FITC — 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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