# K022161: Modification to Coulter LH 750 Hematology Analyzer, Model 6605632

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 29, 2002 after 26 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
Longest line of descent: 1 generation back to K011342 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K011342: Coulter LH 750 Hematology Analyzer, Model 6605632, Beckman Coulter, Inc. (2001)

## Most influential descendants
- K032013: Coulter Act 5DIFF AL Hematology Analyzer (2003), 1 descendant of its own
- K042173: Coulter a T 5DIFF Cap Pierce (CP) (2004), 0 descendants of its own

## Recalls of this device
- Jun 26, 2017 · Class II · Z-3113-2017: Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts
- Nov 8, 2002 · Not classified · Z-0415-03: Software vote out logic changed. Erroneous white blood cell counts.

## Indications for use
The COULTER@LH 750 Hematology Analyzer is a quantitative, automated hematology Analyze; and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER@LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). Future commercialization will add ISOTONB 4 diluent /Lyse S@4 Lytic reagent to the indications for use.

Source page: https://510kreport.com/device/K022161
Methodology: https://510kreport.com/methodology