The Recall Desk
ModerateFDA (Devices)·Z-0808-2013·Announced 2013-02-20

Remel Recalls Oxoid Cefoxitin Antimicrobial Susceptibility Discs Due to Insufficient Dose

Remel Inc is recalling 23 units of Oxoid Cefoxitin Antimicrobial Susceptibility Discs because the cartridges may contain discs with an insufficient antibiotic dose.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves an insufficient antibiotic dose in a diagnostic reagent, which is a quality defect that could impact test accuracy but does not present an immediate physical injury risk to the user, fitting the criteria for a moderate severity voluntary recall.

Plain-English summary

Remel Inc is recalling 23 units of Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B. The product is packaged with 50 discs per cartridge and 5 cartridges per box. The label identifies the responsible firm as Oxoid Ltd., Basingstoke, Hants, UK.

The recall was initiated because the cartridges may contain discs that have an insufficient dose of antibiotic. This issue could affect the accuracy of antimicrobial susceptibility testing results.

The affected product is Lot 1186069. Distribution was nationwide, including California, Connecticut, Georgia, Iowa, Kansas, Oklahoma, Rhode Island, Texas, Washington, and Wisconsin. Users should stop using the product and contact Remel Inc for further instructions.

The recalled product

Product
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.
Manufacturer
Remel Inc
Affected units
23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 1186069

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically: