Advanced Instruments GloCyte® Vacuum Preparation Station Assembly
Model 111076 · Advanced Instruments, LLC · DI 00816068020153
GKL — Counter, Cell, Automated (Particle Counter) · Class II · 21 CFR 864.5200
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 (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2018-02-07 | Z-0640-2019 | Class II | Terminated | RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC. | k number procode |
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-07 | 0 | 2 |
| 2022-12 | 0 | 3 |
Regulatory clearances
- K152776 SESE 2016-05-27 (k number procode)
Predicate lineage
K152776 — cites (transitively): K112605 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Advanced Instruments, LLC
- VAI 2017-08-04 Advanced Instruments, LLC · 4 citations
- VAI 2017-08-04 Advanced Instruments, LLC · 4 citations
- VAI 2012-02-07 Advanced Instruments, LLC · 4 citations
- VAI 2012-02-07 Advanced Instruments, LLC · 4 citations