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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63556

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

Open FDA event record

Event summary

Timeline bucket
August 21, 2012
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

Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

Z-0808-2013
Recall number
Z-0808-2013
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

Code information

Lot 1186069

Distribution pattern

US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,