Recall Z-1982-2019
Beckman Coulter Inc. · initiated September 17, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
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: Software Manufacturing/Software Deployment
Action taken
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.
Details
- Recall number
- Z-1982-2019
- Initiated
- September 17, 2018
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 41 units
- Distribution
- US: CA and NY OUS: United Kingdom, Switzerland and Germany
- Recalling firm
- Beckman Coulter Inc., Brea, CA