# K003677: Abx Pentra 60C+ Hematology Analyzer

- Pathway: 510(k) (Special)
- Applicant: Abx Diagnostics
- Decided: Dec 26, 2000 after 27 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K024002: Pentra 80 (2003), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own
- K030144: Modification to Pentra 60 and Pentra 60C+ (2003), 0 descendants of its own

## Recalls of this device
- Jun 4, 2003 · Not classified · Z-1149-03: Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
- Jan 20, 2003 · Not classified · Z-0570-03: Failure to cycle properly ammong samples.

Source page: https://510kreport.com/device/K003677
Methodology: https://510kreport.com/methodology