Z-3114-2017Class II

Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the...

Name: Z-3114-2017 Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the...
Creator: Beckman Coulter Inc.
Published: 2017-06-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-06-26 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated... on 2017-06-26. 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 LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3114-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-26
Posted: 2017-09-07
Terminated: 2023-09-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
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 LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated June 30, 2017, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff. If they forwarded any of the affected product to another laboratory, please provide them a copy of the letter. Customers with questions should contact the Customer Support Center at 800-528-7694.
Quantity in commerce: 3326 units
Distribution: Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.
Product codes and lots: Catalog Number(s): HMX CP - 178832, 178833, 178834, A91062, A90994; HmX AutoLoader - 6605522, 6605523, 6605524; All software versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3114-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3113-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-07
Z-3114-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-07

Product code GKZ

K010765Class IICoulter Hmx Analyzer, Model 6605523, Coulter Hmx with Autoloader, Model 6605526Beckman Coulter, Inc. / cleared 2001-04-13

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)