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DxH 900 Hematology System C11478

by Beckman Coulter, Inc.

Ref C11478

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-C11478UC Basic UDI-DI D-C11478UCUDI-DIDate8 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-C11478UC UDI-DI Date3 May 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

19 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2573-2025 FDA Class II initiated 13 Aug 2025
    • Ongoing Z-2572-2025 FDA Class II initiated 13 Aug 2025

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    • Terminated Z-0516-2020 FDA Class II initiated 7 Oct 2019

    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. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

  • 3 recalls, same reason

    • Terminated Z-1383-2019 FDA Class I initiated 30 Jul 2018
    • Terminated Z-1384-2019 FDA Class I initiated 30 Jul 2018
    • Terminated Z-1382-2019 FDA Class I initiated 30 Jul 2018

    Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.

  • 3 recalls, same reason

    • Terminated Z-0236-2018 FDA Class II initiated 3 Nov 2017
    • Terminated Z-0238-2018 FDA Class II initiated 3 Nov 2017
    • Terminated Z-0237-2018 FDA Class II initiated 3 Nov 2017

    The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

    • Terminated Z-3101-2017 FDA Class II initiated 20 Jun 2017

    The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.

  • 2 recalls, same reason

    • Terminated Z-2158-2017 FDA Class II initiated 24 Apr 2017
    • Terminated Z-2157-2017 FDA Class II initiated 24 Apr 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 events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.

  • 2 recalls, same reason

    • Terminated Z-1013-2017 FDA Class II initiated 19 Dec 2016
    • Terminated Z-1014-2017 FDA Class II initiated 19 Dec 2016

    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 samples. This is due to limitations in the available technology as well as sample limitations.

    • Terminated Z-2732-2016 FDA Class II initiated 8 Aug 2016

    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.

    • Terminated Z-2692-2016 FDA Class II initiated 4 Aug 2016 on shared 510(k) K140911

    Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.

  • 3 recalls, same reason

    • Terminated Z-0432-2016 FDA Class II initiated 1 Dec 2015
    • Terminated Z-0434-2016 FDA Class II initiated 1 Dec 2015
    • Terminated Z-0433-2016 FDA Class II initiated 1 Dec 2015

    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 (ID) but different Patient identification when manually editing pending orders at the System Manager.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
UniCel® DxH 900 Coulter® Cellular Analysis System EUDAMED
DxH 900 Hematology System GUDID
Generic Name
Haematological cell analyser IVD
Model / Ref / Catalog
C11478
Primary DI / UDI-DI
D-C11478UC EUDAMED
15099590701574 GUDID
Basic UDI-DI
B-C11478UC
510(k) Number
FDA Product Code
GKZ
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
GMDN Term
Haematological cell analyser IVD
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
864.5220
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-C11478UC
GUDID
15099590701574
Device ClassEUDAMED
Class IVD General
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Related devices

Cleared under the same submission (K240252)

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No