Z-1731-2011

Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology Analyzers; Part...

Name: Z-1731-2011 Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology Analyzers; Part...
Creator: Beckman Coulter Inc.
Published: 2010-12-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-12-14 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997... on 2010-12-14. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label...". 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-1731-2011
Status: Terminated
Initiated: 2010-12-14
Posted: 2011-03-18
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000. Quantitative, automated, differential cell counters for in vitro diagnostic use.
Product code: GKZ Counter, Differential Cell
Reason for recall: The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label scanned by the primary mode barcode reader. There is a potential for Specimen or Patient misidentification to occur.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recall communication was initiated on 12/14/2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER HmX Hematology Analyzer, COULTER HmX Hematology Analyzer with Autoloader, COULTER MAXM Analyzer, COULTER MAXM Hematology Analyzer with Autoloader. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed not to use the tilde (~) character in Specimen or Patient identifiers. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
Quantity in commerce: 4288 units total
Distribution: Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya, Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.
Product codes and lots: All serial numbers.

Product code GKZ

K911385Class IICoulter(r) Mh010Coulter Electronics, Inc. / cleared 1991-06-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)