UniCel DxH
UniCel DxH 600 Coulter Cellular Analysis System
3manufacturers in China registered for this device type
3catalogue numbers in this listing
28510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2024-05-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600 | In distribution | |
| 800 | In distribution | |
| 800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Cell-DYN | Abbott Laboratories | 19 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 17 |
| Simultest | Becton, Dickinson AND Company | 10 |
| BD FACSCanto™ | Becton, Dickinson AND Company | 10 |
| FACSCanto | Becton, Dickinson AND Company | 7 |
| BD Multitest | Becton, Dickinson AND Company | 6 |
| Coulter AcT | Beckman Coulter, Inc. | 6 |
| BD™ Multi-Check | Becton, Dickinson AND Company | 6 |
| BD Tritest | Becton, Dickinson AND Company | 6 |
| Coulter LH | Beckman Coulter, Inc. | 5 |
| HemoScreen | Pixcell Medical Inc. | 5 |
Showing 12 of 245. All products under Counter, Differential Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240252 | 2024-07-05 |
| K193124 | 2020-04-16 |
| K182886 | 2019-09-06 |
| K181475 | 2019-03-01 |
| K162414 | 2016-11-29 |
| K140911 | 2014-09-05 |
| K120771 | 2013-03-22 |
| K081930 | 2008-12-19 |
| K081526 | 2008-08-14 |
| K071681 | 2007-10-04 |
| K061616 | 2006-10-04 |
| K061574 | 2006-07-21 |
| K052905 | 2005-11-18 |
| K051122 | 2005-08-01 |
| K050057 | 2005-02-10 |
| K043215 | 2005-01-19 |
| K042724 | 2004-10-29 |
| K042173 | 2004-10-12 |
| K032342 | 2003-09-26 |
| K032000 | 2003-08-13 |
| K032013 | 2003-07-24 |
| K030828 | 2003-05-21 |
| K030606 | 2003-04-21 |
| K030291 | 2003-04-17 |
| K030408 | 2003-03-04 |
| K022161 | 2002-07-29 |
| K011342 | 2001-07-09 |
| K010765 | 2001-04-13 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Beckman Coulter, Inc. | UDI-DI | 2025-08-13 | Class II | Component change control | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| Beckman Coulter, Inc. | UDI-DI | 2025-08-13 | Class II | Component change control | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-08-13 | Class II | Component change control | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. | ||
| 2025-08-13 | Class II | Component change control | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. | ||
| 2019-10-07 | Class II | Under Investigation by firm | When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. E | 1,056 (418 US, and 638 OUS) | 2021-04-27 |
| 2018-07-30 | Class I | Software Design Change | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. | 341 | 2022-03-31 |
| 2018-07-30 | Class I | Software Design Change | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. | 2,059 devices | 2022-03-31 |
| 2018-07-30 | Class I | Software Design Change | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. | 5,414 devices | 2022-03-31 |
| 2018-01-12 | Class I | Nonconforming Material/Component | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application. | 2549 | 2024-04-30 |
| 2018-01-12 | Class I | Nonconforming Material/Component | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application. | 3115 | 2024-04-30 |
| 2017-11-03 | Class II | Device Design | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. | 3 units | 2018-06-19 |
| 2017-11-03 | Class II | Device Design | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. | 15 units | 2018-06-19 |
| 2017-11-03 | Class II | Device Design | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. | 1 unit | 2018-06-19 |
| 2017-06-26 | Class II | Labeling Change Control | 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 in some blood samples. | 3326 units | 2023-09-14 |
| 2017-06-26 | Class II | Labeling Change Control | 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 in some blood samples. | 6763 units | 2023-09-14 |
| 2017-06-20 | Class II | Employee error | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation. | 310 units | 2021-04-21 |
| 2017-04-24 | Class II | Device Design | 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 events associated with the unusual light | 4880 units total (2119 units in US) | 2018-05-22 |
| 2017-04-24 | Class II | Device Design | 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 events associated with the unusual light | 1408 units total (998 units in US) | 2018-05-22 |
| 2016-12-19 | Class II | Under Investigation by firm | 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 flag or detect blasts in some blood sample | 1,282 units total (915 units in US) | 2017-05-12 |
| 2016-12-19 | Class II | Under Investigation by firm | 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 flag or detect blasts in some blood sample | 4,657 units total (2,067 units in US) | 2017-05-12 |
| 2016-08-08 | Class II | Software design | There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. | 5,282 units total (2,877 units in US) | 2017-04-29 |
| 2015-12-01 | Class II | Software design | 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 orders with the same Specimen identification | 3,951 units total (1,975 units in US) | 2017-01-20 |
| 2015-12-01 | Class II | Software design | 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 orders with the same Specimen identification | 834 units total (594 units in US) | 2017-01-20 |
| 2015-12-01 | Class II | Software design | 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 orders with the same Specimen identification | 666 units total (327 units in US) | 2017-01-20 |
| 2013-11-08 | Class II | Under Investigation by firm | 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 cells (nRBC), automated white blood cell di | 164 units total (106 units in US) | 2014-12-25 |
| 2013-11-08 | Class II | Under Investigation by firm | 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 blood cell differential and/or reticulocyte | 1961 units total (610 units in US) | 2014-12-25 |
| 2013-11-08 | Class II | Under Investigation by firm | 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 blood cell differential and/or reticulocyte | 4155 units total (1676 units in US) | 2014-12-25 |
| 2013-11-08 | Class II | Under Investigation by firm | 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 cells (nRBC), automated white blood cell di | 2,874 units total (1696 units in US) | 2014-12-25 |
| 2013-09-24 | Class II | Component change control | 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 at the connection to the Vacuum Overflo | 1,697 units | 2014-10-09 |
| 2013-09-24 | Class II | Under Investigation by firm | 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 investigation indicates that specific lots | 1,025 units | 2014-04-21 |
| 2012-05-22 | Class II | Process control | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-F | 146 units total (37 units in US) | 2012-10-10 |
| 2012-05-22 | Class II | Process control | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-F | 137,445 units total (26,155 units in US) | 2012-10-10 |
| 2012-05-22 | Class II | Process control | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-F | 33,259 units total (8,458 units in US) | 2012-10-10 |
| 2012-04-03 | Class II | Device Design | 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 specimen tube caps, and result in biohazard or | 1281 units total (693 units in the US) | 2013-06-20 |
| 2011-12-01 | Not classified | Software design | 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 Cell Controls assay sheets using the 2D | 8,922 units total (4,073 units in US) | 2014-09-02 |
| 2011-12-01 | Not classified | Software design | 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 Cell Controls assay sheets using the 2D | 8,922 units total (4,073 units in US) | 2014-09-02 |
| 2011-12-01 | Not classified | Software design | 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 Cell Controls assay sheets using the 2D | 8,922 units total (4,073 units in US) | 2014-09-02 |
| 2011-10-13 | Not classified | Nonconforming Material/Component | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. | 1 unit total | 2012-06-01 |
| 2011-10-13 | Not classified | Nonconforming Material/Component | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. | 98 units total | 2012-06-01 |
| 2011-10-13 | Not classified | Nonconforming Material/Component | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. | 6 units total | 2012-06-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.