# K010765: Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 13, 2001 after 30 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jun 26, 2017 · Class II · Z-3114-2017: 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
- Oct 13, 2011 · Not classified · Z-0600-2012: The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
- Oct 13, 2011 · Not classified · Z-0601-2012: 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-2044-2011: 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
- Mar 2, 2011 · Not classified · Z-2043-2011: 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
- Dec 14, 2010 · Not classified · Z-1730-2011: The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a

Source page: https://510kreport.com/device/K010765
Methodology: https://510kreport.com/methodology