UniCel DxH 800 Coulter Cellular Analysis System

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

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

• 2 recalls, same reason

  • Ongoing Z-2574-2025 FDA Class II ·initiated 13 Aug 2025
  • Ongoing Z-2575-2025 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-0433-2016 FDA Class II ·initiated 1 Dec 2015
  • Terminated Z-0434-2016 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.

• • Terminated Z-1616-2015 FDA Class II ·initiated 13 Apr 2015 ·on shared 510(k) K081930

  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 the recall notice may eventually result in a compromised HGB chamber.

• 2 recalls, same reason

  • Terminated Z-1829-2014 FDA Class II ·initiated 8 Nov 2013
  • Terminated Z-1828-2014 FDA Class II ·initiated 8 Nov 2013

  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 differential and the reticulocyte.

• • Terminated Z-0147-2014 FDA Class II ·initiated 24 Sep 2013

  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 of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb

• • Terminated Z-0021-2013 FDA Class II ·initiated 3 Apr 2012

  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 chemical exposure and/or the potential for generating incorrect results.

• • Terminated Z-3125-2011 FDA Unclassified (pre-2012) ·initiated 9 May 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 presentation station. When the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. The misal

• • Terminated Z-2227-2011 FDA Unclassified (pre-2012) ·initiated 14 Apr 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.

• • Terminated Z-2172-2011 FDA Unclassified (pre-2012) ·initiated 11 Feb 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 inverts a cassette The impact: - Specimen tubes may fall out of cassettes and be misplaced inside the instrument - Specimen tubes may break upon impact, causing possible biohazard exposure - Patien

• • Terminated Z-2145-2011 FDA Unclassified (pre-2012) ·initiated 11 Feb 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 to the 9th power cells/L). Beckman Coulter indicated the DIFF% carryover is unlikely to have clinical impact.

• • Terminated Z-2148-2011 FDA Unclassified (pre-2012) ·initiated 11 Feb 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/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact.

• • Terminated Z-2157-2011 FDA Unclassified (pre-2012) ·initiated 11 Feb 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.

• • Terminated Z-1980-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  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 blood borne pathogens such as HIV, HBV, and HCV.

• • Terminated Z-2114-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  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 and not flagged when there is a WBC Pump Failure. IMPACT: Erroneous RBC and/or HCT could affect the interpretation and management of patients at risk with various types of anemias.

• • Terminated Z-2128-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  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 places (comma, ",") and partial units (decimal, "."). An LIS that uses non-US formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid r

• 2 recalls, same reason

  • Terminated Z-1977-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010
  • Terminated Z-1978-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  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 results. IMPACT: Erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu

• • Terminated Z-2121-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  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 processing in CBC panels. RETIC test panel using pre-diluted samples has not been validated. IMPACT: The reticulocyte value is an indicator for assessing red cell production. Erroneous results could impact c

• • Terminated Z-1656-2010 FDA Unclassified (pre-2012) ·initiated 2 Mar 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 function impacting WBC, Differential, Reticulocyte and/or NRBC results. Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files. Impact: If the last run for a control lot

• • Terminated Z-2338-2010 FDA Unclassified (pre-2012) ·initiated 12 Feb 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 for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu

• • Terminated Z-1658-2010 FDA Unclassified (pre-2012) ·initiated 4 Feb 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 @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456'. Issue2: The characters 7 " and * (question mark, quotation mark, and asterisk) used as part

• • Terminated Z-1680-2010 FDA Unclassified (pre-2012) ·initiated 8 Dec 2009

  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 system.

• • Terminated Z-1905-2010 FDA Unclassified (pre-2012) ·initiated 28 Jul 2009

  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, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.

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

Trade Name

UniCel DxH 800 Coulter Cellular Analysis System EUDAMED

UniCel DxH GUDID

Generic Name

Haematological cell analyser IVD

Model / Ref / Catalog

B24802, 800

Primary DI / UDI-DI

D-B24802UJ EUDAMED

15099590672423 GUDID

Basic UDI-DI

B-B24802UJ

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

EUDAMED SRN

US-MF-000010288

Authorised representative

Beckman Coulter Ireland Inc. IE-AR-000000886

• Access Testosterone

  Class B

  CE/IVDR

• Access IL-6

  Class C

  CE/IVDR

• Access Ultrasensitive hGH

  Class B

  CE/IVDR

• Access Thyroglobulin

  Class C

  CE/IVDR

• Access HBs Ag

  IVD Annex II List A

  CE/IVDD

• Access Ultrasensitive Insulin

  Class C

  CE/IVDR

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