Z-1982-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- September 17, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
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
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.
Distribution Pattern
US: CA and NY OUS: United Kingdom, Switzerland and Germany
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