Tosoh G8 Reporting Software Recalled Due to Power Outage Shutdowns
Tosoh Smd Inc is recalling 34 units of Reporting Software for the G8 analyzer because power outages cause the software to shut down.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves software shutdowns during power outages, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tosoh Smd Inc is recalling 34 units of Reporting Software used with the Tosoh Automated HPLC G8 analyzer. The software serves as middleware between the analyzer and a Laboratory Information System (LIS) or as a standalone data repository. It is installed on Dell All-in-One computers that use a Keyspan USB to Serial Adapter to connect to the G8 analyzer.
The recall is due to a defect where power outages cause the reporting software to shut down. The software is designed to store and manage data received from the analyzer and generate reports. The issue arises because the Keyspan adapter's default firmware setting dynamically assigns COM ports, which can change when power is shut down or cables are disconnected, potentially disrupting the data transmission and software operation.
The affected units were distributed nationwide in the states of Connecticut, Massachusetts, Maine, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, Pennsylvania, South Dakota, Texas, Virginia, and West Virginia. The recall applies to all G8 analyzers with Reporting Software interfaced with an LIS. Users should contact Tosoh Smd Inc for further instructions on resolving the software shutdown issue.
The recalled product
- 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…
- Manufacturer
- Tosoh Smd Inc
- Affected units
- 34
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All G8's with Reporting Software interfaced with LIS.
Distribution
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