# K061616: Coulter LH 780 Hematology Analyzer

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 4, 2006 after 118 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912494 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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) Summary page 1.
- K030606: Coulter LH 750 Body Fluids Application, Beckman Coulter, Inc. (2003) Summary page 1.
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer, Sysmex Corp. (1999) Summary page 1.

## Most influential descendants
- K081930: Unicel DXH 800 Coulter Cellular Analysis System (2008), 0 descendants of its own

## Recalls of this device
- Jul 22, 2015 · Class II · Z-2481-2015: Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
- Jul 22, 2015 · Class II · Z-2480-2015: Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
- Nov 8, 2013 · Class II · Z-0471-2014: Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blo
- Sep 24, 2013 · Class II · Z-0113-2014: The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak
- Dec 1, 2011 · Not classified · Z-1241-2012: The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C
- Jan 31, 2011 · Not classified · Z-1954-2011: This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will
- Apr 18, 2007 · Not classified · Z-0313-2008: Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation wil

## Indications for use
The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

Source page: https://510kreport.com/device/K061616
Methodology: https://510kreport.com/methodology