Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6605522,

FDA device recall Z-1730-2011 · posted 2011-03-18 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

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, Buru

Date initiated

2010-12-14

Date posted

2011-03-18

Date terminated

2014-09-02

Location

Brea, CA

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