Z-1982-2019Class II

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software...

Name: Z-1982-2019 Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software...
Creator: Beckman Coulter Inc.
Published: 2018-09-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-09-17 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of 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... on 2018-09-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1982-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-17
Posted: 2019-07-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: 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
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1982-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1982-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-17

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)