The Recall Desk
ModerateFDA (Devices)·Z-0792-2014·Announced 2014-01-29

Remel Recalls Oxoid Cefpodoxime Antimicrobial Susceptibility Test Discs

Remel Inc is recalling Oxoid Cefpodoxime 10 mcg. Antimicrobial Susceptibility Test Discs because some cartridges may contain discs not impregnated with 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, and the hazard involves a quality defect (missing antibiotic) that could lead to incorrect test results, but no injuries or illnesses are reported.

Plain-English summary

Remel Inc is recalling 9 packs of Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B. The product is packaged in cartridges of 50 discs, with 5 cartridges per pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. The affected lot number is 1275353, with an expiration date of 31Dec2015.

The recall was initiated because cartridges may contain individual discs which were not impregnated with antibiotic. These discs are 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.

The product was distributed nationwide in the US, including Puerto Rico. Users should stop using the affected discs and contact Remel Inc for further instructions.

The recalled product

Product
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 su
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Test Kit
Hazard
Affected units
9

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 1275353
  • Exp. 31Dec2015

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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