The Recall Desk
ModerateFDA (Devices)·Z-0794-2014·Announced 2014-01-29

Remel Recalls Oxoid Ampicillin Test Discs Due to Missing Antibiotic

Remel Inc is recalling 80 packs of Oxoid Ampicillin 10 mcg 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 functional defect (missing antibiotic) that could lead to inaccurate test results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Remel Inc is voluntarily recalling 80 packs of Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg (Lot 1215912, Exp. 31Jul2015). 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 recall was initiated because the cartridges may contain individual discs that 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 determining a suitable antibiotic agent for treatment purposes.

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

The recalled product

Product
Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, 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 Kits
Hazard
Affected units
80

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 1215912
  • Exp. 31Jul2015

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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Same hazard · inaccurate test results

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