The Recall Desk
ModerateFDA (Devices)·Z-0795-2014·Announced 2014-01-29

Remel Recalls Oxoid Ertapenem Antimicrobial Susceptibility Test Discs

Remel Inc is recalling Oxoid Ertapenem 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. The hazard involves a quality defect (missing antibiotic impregnation) that could lead to inaccurate test results, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Remel Inc is recalling 30 packs of Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B. 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. These discs are used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to help determine suitable antibiotic agents for treatment.

The recall was initiated because cartridges may contain individual discs which were not impregnated with antibiotic. The affected product is identified by Lot 1227786, with an expiration date of 31AUG2013.

The product was distributed nationwide, including the United States and 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, Ertapenem 10 mcg., CT1761B, 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 susc
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Test Kits
Hazard
Affected units
30

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 1227786
  • Exp. 31AUG2013

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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