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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95458

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

Open FDA event record

Event summary

Timeline bucket
September 20, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
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 BactiDrop Acridine Orange, REF 21502, 50 per package.

Z-0266-2025
Recall number
Z-0266-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Remel, Inc
Quantity
29 kits

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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 color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

Code information

Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.

Distribution pattern

Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the United Kingdom.