The Recall Desk
LowFDA (Devices)·Z-0528-2014·Announced 2013-12-25

Remel Recalls Oxoid Ciprofloxacin Test Discs Due to Labeling Error

Remel Inc is recalling Oxoid Ciprofloxacin test discs because boxes labeled CIP5 may contain AMP5 cartridges.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a labeling error rather than a direct safety hazard.

Plain-English summary

Remel Inc is recalling Oxoid Antimicrobial Susceptibility Test Discs, specifically the CTO425B Ciprofloxacin CIP 5 mcg product. The recall is due to a labeling error where boxes labeled as CIP5 may contain cartridges of AMP5.

The affected product is used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in determining suitable antibiotic agents. The recall involves 60 boxes of 5-cartridge packs containing 50 discs each. The specific lot number is 1220205, with an expiration date of July 21, 2015.

The product was distributed nationwide, including in Alabama, California, Colorado, Florida, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. Users should stop using the affected discs and contact Remel Inc for instructions.

The recalled product

Product
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility te
Manufacturer
Remel Inc

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 (3)

  • Lot number: 1220205
  • exp July 21
  • 2015

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically: