# K011342: Coulter LH 750 Hematology Analyzer, Model 6605632

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 9, 2001 after 68 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 8 cite it directly.
0 of 13 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
- K032342: Coulter LH 750 Hematology Analyzer (2003), 2 descendants of its own
- K022161: Modification to Coulter LH 750 Hematology Analyzer, Model 6605632 (2002), 2 descendants of its own
- K061616: Coulter LH 780 Hematology Analyzer (2006), 1 descendant of its own
- K041882: Flowcare System (2004), 1 descendant of its own
- K032000: Coulter LH 500 Hematology Analyzer (2003), 1 descendant 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
- 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-0470-2014: 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-1242-2012: 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-1953-2011: 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-0312-2008: 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
- Sep 12, 2006 · Not classified · Z-0566-2007: There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid m
- Dec 15, 2005 · Not classified · Z-0474-06: There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
- Mar 31, 2004 · Not classified · Z-0905-04: If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sampl
- Jan 10, 2003 · Not classified · Z-0541-03: Biohazard situation exists for users.
- Dec 27, 2002 · Not classified · Z-0669-03: Incorrect Hemoglobin result can be reported with software version 2A and higher.
- Dec 10, 2002 · Not classified · Z-0571-03: Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
- Nov 8, 2002 · Not classified · Z-0415-03: Software vote out logic changed. Erroneous white blood cell counts.

Source page: https://510kreport.com/device/K011342
Methodology: https://510kreport.com/methodology