Exact FDA event identifier

Event 80585

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

Open FDA event record

Event summary

Timeline bucket: July 13, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Tosoh Bioscience 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

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

Z-3244-2018

Recall number: Z-3244-2018
Initiated: July 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Tosoh Bioscience Inc
Quantity: 8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Analyzers were distributed with software which lacks a 510K

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Analyzers were distributed with software which lacks a 510K

Code information

Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201

Distribution pattern

US Nationwide Distribution in states of - CA, OK, VA 7 WI