# K081930: Unicel DXH 800 Coulter Cellular Analysis System

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 19, 2008 after 165 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912494 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
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.
- K061616: Coulter LH 780 Hematology Analyzer, Beckman Coulter, Inc. (2006) Summary page 1.

## Recalls of this device
- Apr 24, 2017 · Class II · Z-2158-2017: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The 
- Apr 24, 2017 · Class II · Z-2157-2017: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The 
- Dec 19, 2016 · Class II · Z-1013-2017: Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not fl
- Dec 19, 2016 · Class II · Z-1014-2017: Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not fl
- Dec 1, 2015 · Class II · Z-0433-2016: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple order
- Dec 1, 2015 · Class II · Z-0434-2016: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple order
- Dec 1, 2015 · Class II · Z-0432-2016: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple order
- Apr 13, 2015 · Class II · Z-1616-2015: Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in th
- Nov 8, 2013 · Class II · Z-1828-2014: Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cel
- Nov 8, 2013 · Class II · Z-1829-2014: Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cel
- Sep 24, 2013 · Class II · Z-0147-2014: Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal in
- Apr 3, 2012 · Class II · Z-0021-2013: Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specime
- May 9, 2011 · Not classified · Z-3125-2011: The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube
- Apr 14, 2011 · Not classified · Z-2227-2011: The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.
- Feb 11, 2011 · Not classified · Z-2172-2011: The recall was initiated because: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inv
- Feb 11, 2011 · Not classified · Z-2145-2011: The recall was initiated because the DxH 800 may fail to meet the carryover specification for the WBC Differential (DIFF) when the WBC is greater than 70 X 10 to the 3rd power cells/micro L (70 X 10 t
- Feb 11, 2011 · Not classified · Z-2157-2011: The recall was initiated because: The handheld barcode scanner does not read barcode labels using NW 7 symbology. Impact: Specimens with NW7 labels cannot be read by the handheld scanner.
- Feb 11, 2011 · Not classified · Z-2148-2011: The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells
- Oct 20, 2010 · Not classified · Z-1978-2011: There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous
- Oct 20, 2010 · Not classified · Z-1980-2011: Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to b
- Oct 20, 2010 · Not classified · Z-2128-2011: Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths pl
- Oct 20, 2010 · Not classified · Z-2121-2011: RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processin
- Oct 20, 2010 · Not classified · Z-1977-2011: There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous
- Oct 20, 2010 · Not classified · Z-2114-2011: For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels: The RBC is improperly corrected an
- Mar 2, 2010 · Not classified · Z-1656-2010: Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic func
- Feb 12, 2010 · Not classified · Z-2338-2010: 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-1658-2010: Issue 1: The system will substitute or omit the characters # @ 1 \ ] ' ( I ) - when the instrument is configured in a language other than English, Chinese or Japanese. Example: Using the character @, 
- Dec 8, 2009 · Not classified · Z-1680-2010: The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host s
- Jul 28, 2009 · Not classified · Z-1905-2010: The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results,

## Indications for use
The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides: · a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood · a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

Source page: https://510kreport.com/device/K081930
Methodology: https://510kreport.com/methodology