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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76173

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tosoh Smd Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1245-2017
Recall number
Z-1245-2017
Initiated
December 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Tosoh Smd Inc
Quantity
34

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Power outages causes reporting software to shutdown.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Power outages causes reporting software to shutdown.

Code information

All G8's with Reporting Software interfaced with LIS.

Distribution pattern

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