Device Recall COULTER HmX Hematology Analyzer 의 리콜

Recall

58174

Class 2

Z-2043-2011

2011-03-02

2011-04-20

Terminated

United States

2012-05-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98585

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.

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.