The Recall Desk
ModerateFDA (Devices)·Z-0793-2014·Announced 2014-01-29

Remel Recalls Oxoid Norfloxacin Antimicrobial Susceptibility Test Discs

Remel Inc is recalling Oxoid Norfloxacin 10 mcg antimicrobial susceptibility test discs because some cartridges may contain discs not impregnated with the antibiotic.

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 a manufacturing defect (missing antibiotic) that could lead to inaccurate test results, but no injuries or illnesses are reported, and the risk is theoretical rather than immediate physical harm.

Plain-English summary

Remel Inc is recalling 10 packs of Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg, CT0434B. The product is packaged in cartridges of 50 discs, with 5 cartridges per pack. The label identifies the firm as Oxoid Ltd., Basingstoke, Hampshire, England. The recalled items are identified by Lot 1192177 and have an expiration date of May 31, 2015.

The recall was initiated because the cartridges may contain individual discs that were not impregnated with the antibiotic. These discs are used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in determining a suitable antibiotic agent for treatment purposes.

The product was distributed nationwide in the United States, including Puerto Rico. The source text does not specify specific end-users or facilities, but the product is intended for laboratory use. No illnesses or injuries are reported in the source text.

The recalled product

Product
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 su
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Test Kit
Hazard
Affected units
10

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 (2)

  • Lot 1192177
  • Exp. Exp. 31May2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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