The Recall Desk
ModerateFDA (Devices)·Z-1246-2014·Announced 2014-03-26

Remel Recalls Oxoid Vancomycin Susceptibility Discs Due to Impregnation Defect

Remel Inc is recalling Oxoid Vancomycin 30 mcg susceptibility discs because some may lack the antibiotic, potentially affecting in-vitro testing results.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.

Plain-English summary

Remel Inc is voluntarily recalling Oxoid Vancomycin 30 mcg susceptibility discs, product code CT0058B. The recall involves 40/5/50-disc cartridge packages from Lot 1174497, which have an expiration date of 2015/04. These products were distributed nationwide.

The recall is being issued because some of the discs may not be impregnated with the antibiotic. These discs are used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing. The label identifies the firm as Oxoid Ltd., Basingstoke, Hampshire, England.

The FDA has classified this as a Class II recall. Users should stop using the affected lots and contact Remel Inc for further instructions or a replacement.

The recalled product

Product
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. 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.
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 (2)

  • Lot 1174497
  • exp. 2015/04

Distribution

Distributed nationwide across the United States.

Same hazard · defective product

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