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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76043

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
The Binding Site Group, Ltd.

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

Digital RID Plate Reader and Software Product Code: AD400

Z-1055-2017
Recall number
Z-1055-2017
Initiated
October 09, 2012
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

Code information

UDI 05051700000376

Distribution pattern

U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.