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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86926

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

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Event summary

Timeline bucket
November 18, 2020
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

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Z-0943-2021
Recall number
Z-0943-2021
Initiated
November 18, 2020
Classification
Class II
Status
Terminated
Quantity
213 kits in the U.S.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

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

Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

Code information

Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Distribution pattern

U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided