Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. OUS: United Kingdom, Switzerland and Germanyġ A record in this database is created when a firm initiates a correction or removal action. If you have questions regarding the notification, please contact 1-80. Install Kaluza C version 1.1 on systems used for analysis. Click the link in the registration email to download Kaluza C version 1.1.Ĥ. Click 'Download Kaluza C1.1' and fill in the requested information.ģ. Navigate to and click the 'Download' icon.Ģ. Installation of Kaluza C version 1.1 will prevent software crashes and result in proper keyword value being transmitted for all samplesġ. The recall letter also ask their customers to visit the Beckman Coulter website to download version Kaluza C 1.1 and install on all affected systems. Please report any erroneous transmissions to Beckman Coulter. Summit Software - Summit Event Management Software - Summit Contact Management Software - Summit Membership. Beckman Coulter ask that if you are using a LIS, please review all previous LIS transmissions which included keywords for accuracy by comparing keywords displayed in Kaluza C Information Plots to those in the LIS system. Beckman Coulter Summit Software Download. Software Manufacturing/Software DeploymentĪn 'Urgent Medical Device Recall' letter was sent on Septemvia email to all affected customers.

The compatibility issue causes the software to be unusable which could result in a delay of reporting results. C21166/UDI: 15099590705169Ĭompatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. (H) Kaluza C 5 User Network Educational LicenseĪ. (G) Kaluza C 10 User Network Educational License (F) Kaluza C Single User 1 Year educational License (E) Kaluza C Perpetual Educational License Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. Class 2 Device Recall Kaluza C Flow Cytometry SoftwareĬalculator/data processing module, for clinical use - Product Code JQP

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