Z-1245-2017Class II

Keyspan High-High Speed USB to Serial Adapter

Name: Z-1245-2017 Keyspan High-High Speed USB to Serial Adapter
Creator: Tosoh Smd Inc
Published: 2016-12-22
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2016-12-22 / Terminated / root cause: software

FDA source

Tosoh Smd Inc began a recall of 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... on 2016-12-22. FDA classified it as Class II and gives the reason as "Power outages causes reporting software to shutdown". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1245-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-22
Posted: 2017-02-22
Terminated: 2019-06-18
Recalling firm: Tosoh Bioscience Inc
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.
Product code: PQQ Data Acquisition Software
Reason for recall: Power outages causes reporting software to shutdown.
Root cause tag: software
FDA root cause: Software design
Action: Tosoh Bioscience sent a Customer Recall Notification letter dated December 21, 2016 to customers. The letter identified the affected product, problem and action to be taken. For questions call Tosoh Technical Support at 800-248-6764.
Quantity in commerce: 34
Distribution: US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.
Product codes and lots: All G8's with Reporting Software interfaced with LIS.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1245-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code PQQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)