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U.S. Department of Health and Human Services

Class 2 Device Recall Keyspan Adapter

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  Class 2 Device Recall Keyspan Adapter see related information
Date Initiated by Firm December 22, 2016
Create Date February 22, 2017
Recall Status1 Terminated 3 on June 18, 2019
Recall Number Z-1245-2017
Recall Event ID 76173
Product Classification Data acquisition software - Product Code PQQ
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.
Code Information All G8's with Reporting Software interfaced with LIS.
Recalling Firm/
Manufacturer		 Tosoh Smd Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Susan H. Koss
614-317-1909
Manufacturer Reason
for Recall		 Power outages causes reporting software to shutdown.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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