ModerateClass IITerminated

FDA Devices recall · Reported March 1, 2017

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 Adapt

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1245-2017.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Power outages causes reporting software to shutdown.

Recall #: Z-1245-2017
Affected scope: 34
Initiated: December 22, 2016

Compiled from official public sources by the publisher. · Updated September 2026

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Tosoh Smd Inc recalled Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software i… - a moderate-severity action.

Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software i… was recalled by Tosoh Smd Inc in March 1, 2017. Reason: Power outages causes reporting software to shutdown.. Check the official notice for the remedy. Verify recall #Z-1245-2017 with the FDA Devices before acting.

The recall

Tosoh Smd Inc issued this moderate-severity FDA Devices recall-Power outages causes reporting software to shutdown..

Moderate
severity level: 34 units
affected scope: Class II
classification: March 1, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1245-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1245-2017
Date reported	March 1, 2017
Date initiated	December 22, 2016
Recalling firm	Tosoh Smd Inc
Firm location	Grove City, OH
Affected scope	34
Distribution	US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

34 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1245-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Power outages causes reporting software to shutdown.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1245-2017.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported March 1, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026