FDA Device recall Z-1245-2017
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between t…
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between t… by Tosoh Smd, citing power outages causes reporting software to shutdown.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-22 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Smd |
| Distribution | US |
Product
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.
Reason
Power outages causes reporting software to shutdown.
Identifiers
| code_info | All G8's with Reporting Software interfaced with LIS. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2017%22
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