Z-2043-2011

COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hematology Analyzer is...

Name: Z-2043-2011 COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hematology Analyzer is...
Creator: Beckman Coulter Inc.
Published: 2011-03-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-03-02 / Terminated

FDA source

Beckman Coulter Inc. began a recall of COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and... on 2011-03-02. The reason FDA records is "The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology analyzer". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2043-2011
Status: Terminated
Initiated: 2011-03-02
Posted: 2011-04-20
Terminated: 2012-05-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology analyzer.
FDA root cause: Other
Action: The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated March 2, 2011, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER LH 500 Series Analyzer, COULTER HmX Hematology Analyzer, and COULTER HmX Hematology Analyzer with Autoloader. The letter described the product, problem and actions to be taken. Customers were informed that the suspect Integrated Circuit Chips have been removed from all systems in inventory and manufacturing. The customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers have forwarded any of the affected product(s) listed on the PCA letter to another laboratory, please provide a copy of the letter to them. The customers were instructed to complete and return the enclosed Response Form within 10 days so Beckman are assured they have received this important communication and are taking appropriate action. The customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States and Canada or contact their local Beckman Coulter Representative.
Quantity in commerce: 288 units total (158 in US)
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.
Product codes and lots: N/A

Product code GKZ

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

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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)