Z-1013-2017Class II

UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304

Name: Z-1013-2017 UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Creator: Beckman Coulter Inc.
Published: 2016-12-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-12-19 / Terminated

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304 on 2016-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1013-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Posted: 2017-01-11
Terminated: 2017-05-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Product code: GKZ Counter, Differential Cell
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated December 19, 2016, to all affected customers to inform them that 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. The letter informs the customers of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the United States and Canada, and outside the United States and Canada, to contact their local Beckman Coulter Representative.
Quantity in commerce: 4,657 units total (2,067 units in US)
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
Product codes and lots: Serial Numbers: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1013-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1013-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11
Z-1014-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code GKZ

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)