Z-2651-2014Class II

Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a...

Name: Z-2651-2014 Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a...
Creator: Beckman Coulter Inc.
Published: 2014-08-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-25 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent... on 2014-08-25. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2651-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-25
Posted: 2014-09-16
Terminated: 2015-02-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.
Product code: GIF Diluent, Blood Cell
Reason for recall: Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated August 25, 2014, to all customers that purchased the Coulter DxH Diluent. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions were instructed to contact Beckman Coulter's Customer Support Center at http://www.beckmancoulter.com, or call (800) 526-7694 in the US and Canada.
Quantity in commerce: 46,050 units total (40,078 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .
Product codes and lots: Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2651-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2651-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-16

Product code GIF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)