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
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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.
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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
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For Additional Information Contact |
Susan H. Koss 614-317-1909
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Manufacturer Reason for Recall |
Power outages causes reporting software to shutdown.
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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
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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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