Z-0237-2018Class II

UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as...

Name: Z-0237-2018 UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as...
Creator: Beckman Coulter Inc.
Published: 2017-11-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-11-03 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit... on 2017-11-03. FDA classified it as Class II and gives the reason as "The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0237-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2017-12-13
Terminated: 2018-06-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Product code: GKZ Counter, Differential Cell
Reason for recall: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."
Quantity in commerce: 1 unit
Distribution: CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Product codes and lots: Serial Number AZ06682

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0237-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0236-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0237-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0238-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13

Product code GKZ

K140911Class IIUnicel Dxh 800 Coulter Cellular Analysis System/ Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. / cleared 2014-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)