# K880636: Reticcount Software

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Mar 21, 1988 after 34 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990327: Reticone System for Epics XL Flow Cytometry Systems (1999), 0 descendants of its own
- K953302: Facs Loader System (1995), 0 descendants of its own

## Recalls of this device
- Mar 18, 2016 · Class III · Z-1390-2016: The 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 Instructions for Use are correct.

Source page: https://510kreport.com/device/K880636
Methodology: https://510kreport.com/methodology