Beckman Coulter Inc.: 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 L

Is my product affected?

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 Si

• UPC 15099590705084
• UPC 15099590705091
• UPC 15099590705114
• UPC 15099590705107
• UPC 15099590705121
• UPC 15099590705138
• UPC 15099590705145
• UPC 15099590705152
• UPC 15099590705169

Check against the official notice below — it lists the full affected range.

What happened

Beckman Coulter Inc. is recalling Kaluza C Flow Cytometry Software due to a compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. This compatibility problem renders the software unusable and could delay the reporting of test results. The recall affects 41 units that were distributed in California and New York in the United States, as well as in the United Kingdom, Switzerland, and Germany.

The affected software includes nine specific lot codes with corresponding UDI numbers ranging from C10574 through C21166. The recall applies to both Kaluza C Perpetual License and Kaluza C Single Use 1 Year License versions of the software. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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: US: CA and NY OUS: United Kingdom, Switzerland and Germany Quantity: 41 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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