Exact FDA event identifier

Event 67099

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

Open FDA event record

Event summary

Timeline bucket: November 21, 2013
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 Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

Z-0734-2014

Recall number: Z-0734-2014
Initiated: November 21, 2013
Classification: Class II
Status: Terminated
Recalling firm: Remel Inc
Quantity: 45/5/50 - discs/cartridges/packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

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

Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

Code information

Lot number: 1223566 EXP: 8/31/2013

Distribution pattern

Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV