Kaluza C recallZ-1982-2019 · Beckman Coulter Inc. · initiated Sep 17, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software Manufacturing/Software Deployment
What the company is doing
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.
Recall details
- Recall number
- Z-1982-2019
- Status
- Terminated
- Initiated by the company
- Sep 17, 2018
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 41 units
- Product code
- JQP
- Distribution
- US: CA and NY OUS: United Kingdom, Switzerland and Germany
Product description
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 (models, lots, serial numbers)
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
Devices named in this recall
9 devices in the FDA device registry whose identifier appears in the recall's code information.
- Kaluza C Perpetual LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Single Use 1 Year LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 10 User NetworkBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 5 User NetworkBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Perpetual Education LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Single User 1 Year Educational LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 10 User Network Educational LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 5 User Network Educational LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Flow Cytometry SoftwareBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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