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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76131

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

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Event summary

Timeline bucket
December 23, 2016
Product types
Device
Classifications
Class III
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

Optilite IgG4 Kit Product Code: LK009.OPT.A

Z-1089-2017
Recall number
Z-1089-2017
Initiated
December 23, 2016
Classification
Class III
Status
Terminated
Quantity
9 users

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

Code information

Lot #401413

Distribution pattern

U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.