PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 24, 2019 Initiated: September 17, 2018 #Z-1982-2019

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.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
41 units
Distribution
US: CA and NY OUS: United Kingdom, Switzerland and Germany
Location
Brea, CA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Beckman Coulter Inc.. Units affected: 41 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1982-2019.

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