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U.S. Department of Health and Human Services

Class 2 Device Recall Kaluza C Flow Cytometry Software

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  Class 2 Device Recall Kaluza C Flow Cytometry Software see related information
Date Initiated by Firm September 17, 2018
Create Date July 17, 2019
Recall Status1 Terminated 3
Recall Number Z-1982-2019
Recall Event ID 82919
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices:

(A) Kaluza C Perpetual License
(B) Kaluza C Single Use 1 Year License
(C) Kaluza C 5 User Network
(D) Kaluza C 10 User Network
(E) Kaluza C Perpetual Educational License
(F) Kaluza C Single User 1 Year educational License
(G) Kaluza C 10 User Network Educational License
(H) Kaluza C 5 User Network Educational License
(I) Kaluza C Flow Cytometry Software
Code Information A. C10574/UDI: 15099590705084 B. C10575/UDI: 15099590705091 C. C10576/UDI: 15099590705114 D. C10577/UDI: 15099590705107 E. C10578/UDI: 15099590705121 F. C10579/UDI: 15099590705138 G. C10580/UDI: 15099590705145 H. C10581/UDI: 15099590705152 I. C21166/UDI: 15099590705169
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Nancy Nadler
469-961-4941
Manufacturer Reason
for Recall		 Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action An "Urgent Medical Device Recall" letter was sent on September 18, 2018 via email to all affected customers. 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. Please report any erroneous transmissions to Beckman Coulter. 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. Installation of Kaluza C version 1.1 will prevent software crashes and result in proper keyword value being transmitted for all samples 1. Navigate to http://www.kaluzasoftware.com and click the "Download" icon. 2. Click "Download Kaluza C1.1" and fill in the requested information. 3. Click the link in the registration email to download Kaluza C version 1.1. 4. Install Kaluza C version 1.1 on systems used for analysis. If you have questions regarding the notification, please contact 1-800-369-0333.
Quantity in Commerce 41 units
Distribution US: CA and NY OUS: United Kingdom, Switzerland and Germany
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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