Keyspan High-High Speed USB to Serial Adapter Product Usage: The… — Class II medical device recall Z-1245-2017
Terminated recall by Tosoh Smd Inc, reported 2017-03-01, distributed nationwide. Power outages causes reporting software to shutdown.
| Recall number | Z-1245-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Smd Inc, Grove City, OH, United States |
| Recall initiated | 2016-12-22 |
| Classified | 2017-02-22 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2019-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 34 |
| Reason classes | software |
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 for recall
Power outages causes reporting software to shutdown.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1245-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.