FDA Device Intelligence
Home › Device types › GKL

Counter, Cell, Automated (Particle Counter)

FDA product code GKL · Class 2 · Hematology

37
Registered devices
215
Adverse events
10
Recalls
130
510(k) clearances

Devices with this code

ADVIA 120/2120/2120i® OPTIpoint — Siemens Healthcare Diagnostics Inc.Advanced Instruments GloCyte® Vacuum Preparation Station Assembly — Advanced Instruments, LLCCOULTER Latron — Beckman Coulter, Inc.BD Retic-Count™ — BECTON, DICKINSON AND COMPANYIVOS — HAMILTON THORNE, INC.ADVIA 120/2120/2120i® AUTOretic — Siemens Healthcare Diagnostics Inc.Automated Hematology Analyzer pocH-100i — SYSMEX CORPORATIONAdvanced Instruments GloCyte® Count Template Cartridge — Advanced Instruments, LLCAdvanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene — Advanced Instruments, LLCADVIA 120/2120/2120i® Sheath/Rinse — Siemens Healthcare Diagnostics Inc.Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume — Advanced Instruments, LLCADVIA 120/2120/2120i® autoRETIC — Siemens Healthcare Diagnostics Inc.Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit — Advanced Instruments, LLCADVIA 120/2120/2120i® Perox Sheath — Siemens Healthcare Diagnostics Inc.Advanced Instruments GloCyte® Automated Cell Counter System — Advanced Instruments, LLCADVIA 120/2120/2120i® Defoamer — Siemens Healthcare Diagnostics Inc.Advanced Instruments GloCyte® Instrument Assembly — Advanced Instruments, LLCAdvanced Instruments GloCyte® Pipette, 10µL Fixed Volume — Advanced Instruments, LLCADVIA 120/2120/2120i® DIFF TIMEpac — Siemens Healthcare Diagnostics Inc.BD Retic-Count™ — BECTON, DICKINSON AND COMPANYAdvanced Instruments RBC Reagent Filtration Kit — Advanced Instruments, LLCADVIA 120/2120/2120i® Sheath/Rinse — Siemens Healthcare Diagnostics Inc.Automated Hematology Analyzer XP series XP-300 — SYSMEX CORPORATIONCOULTER Latron CP-X — Beckman Coulter, Inc.

Recent recalls

DateFirmReason
2018-02-07Advanced Instruments, LLCRBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient sam
2016-03-18Becton, Dickinson and Company, BD BiosciencesThe carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instru
2014-12-19BD Biosciences, Systems & ReagentsOne lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
2013-06-26Siemens Healthcare DiagnosticsThe ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SM
2011-01-31Beckman Coulter Inc.This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). S
2007-04-18Beckman Coulter IncPatient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is alread
2006-03-16Bayer Healthcare, LLC (Diagnostics Division)The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Plate
2004-02-13Beckman Coulter IncSoftware anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using
2004-02-13Beckman Coulter IncSoftware anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using
2004-02-13Beckman Coulter IncSoftware anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.