Recalls / —

—#98585

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.

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K010765

Affected lot / code info

N/A

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc.

Address

200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern

Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.

Timeline

Recall initiated

2011-03-02

Posted by FDA

2011-04-20

Terminated

2012-05-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #98585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.