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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65184

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 09, 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

4 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 4

Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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-0792-2014
Recall number
Z-0792-2014
Initiated
April 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
9 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cartridges may contain individual discs which were not impregnated with antibiotic.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cartridges may contain individual discs which were not impregnated with antibiotic.

Code information

Lot 1275353, Exp. 31Dec2015

Distribution pattern

Nationwide Distribution: US including Puerto Rico.

device · product 2 of 4

Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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-0793-2014
Recall number
Z-0793-2014
Initiated
April 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
10 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cartridges may contain individual discs which were not impregnated with antibiotic.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cartridges may contain individual discs which were not impregnated with antibiotic.

Code information

Lot 1192177, Exp. Exp. 31May2015

Distribution pattern

Nationwide Distribution: US including Puerto Rico.

device · product 3 of 4

Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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-0794-2014
Recall number
Z-0794-2014
Initiated
April 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
80 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cartridges may contain individual discs which were not impregnated with antibiotic.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cartridges may contain individual discs which were not impregnated with antibiotic.

Code information

Lot 1215912, Exp. 31Jul2015

Distribution pattern

Nationwide Distribution: US including Puerto Rico.

device · product 4 of 4

Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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-0795-2014
Recall number
Z-0795-2014
Initiated
April 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
30 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cartridges may contain individual discs which were not impregnated with antibiotic.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cartridges may contain individual discs which were not impregnated with antibiotic.

Code information

Lot 1227786, Exp. 31AUG2013

Distribution pattern

Nationwide Distribution: US including Puerto Rico.

Field note

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