Z-1831-2014Class II

Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact...

Name: Z-1831-2014 Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact...
Creator: Beckman Coulter Inc.
Published: 2013-11-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-11-08 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples on 2013-11-08. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1831-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2014-06-20
Terminated: 2014-12-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
Product code: JCB Detergent
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: An Urgent Product Correction letter, dated 11/08/2013, was sent to all the customers who purchased the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, via phone at (800) 526-7694 in US and Canada. For outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative. Beckman Coulter sent an update on 2/14/14, to inform customers that the recall was expanded to include specific lots of DxH Cleaner.
Quantity in commerce: 12,924 units total (9,733 units in US)
Distribution: Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: Lot No. 3040210 3040330 3043090 3043100 3057970 3057980 3058130 3071440 3071450

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20
Z-1829-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20
Z-1830-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20
Z-1831-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20

Product code JCB

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)