# K032000: Coulter LH 500 Hematology Analyzer

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 13, 2003 after 64 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 9 (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.
1 later device descends from it; 1 cites 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)
- K011342: Coulter LH 750 Hematology Analyzer, Model 6605632, Beckman Coulter, Inc. (2001)

## Most influential descendants
- K042724: Modification to Coulter LH 500 Hematology Analyzer (2004), 0 descendants of its own

## Recalls of this device
- Dec 1, 2011 · Not classified · Z-1243-2012: 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
- Oct 13, 2011 · Not classified · Z-0599-2012: The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
- Mar 2, 2011 · Not classified · Z-2042-2011: The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology anal
- Jan 31, 2011 · Not classified · Z-1955-2011: 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
- Feb 12, 2010 · Not classified · Z-2337-2010: The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential f
- Feb 4, 2010 · Not classified · Z-1657-2010: Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in th
- Apr 18, 2007 · Not classified · Z-0314-2008: 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
- Apr 17, 2006 · Not classified · Z-1245-06: Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
- Aug 12, 2004 · Not classified · Z-1433-04: Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an inc

## Indications for use
The COULTERB LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi-automated reticulocyte analysis.

Source page: https://510kreport.com/device/K032000
Methodology: https://510kreport.com/methodology