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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69629

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

Open FDA event record

Event summary

Timeline bucket
October 29, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Remel 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

Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

Z-0449-2015
Recall number
Z-0449-2015
Initiated
October 29, 2014
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
79/5/250- packages/bottles/ml

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

Code information

Lot: 293086 Expiration 01Apr2015

Distribution pattern

Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.