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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69856

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

Open FDA event record

Event summary

Timeline bucket
November 20, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Unistrip Technologies LLC

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

UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

Z-0855-2015
Recall number
Z-0855-2015
Initiated
November 20, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unistrip Technologies LLC
Quantity
7175 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failure to submit a 510(k) for device labeling changes.

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

Failure to submit a 510(k) for device labeling changes.

Code information

U14030713, 814031313, U140312323, and U14031413.

Distribution pattern

US Distribution to the states of FL and OH.