CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report

Oxoid Antimicrobial Susceptibility Test Discs recalled by Remel

Remel is recalling Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, distributed nationwide in the US. The recall was initiated on 9 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1215912, Exp. 31Jul2015

Quantity recalled80 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0794-2014
FDA event ID: 65184
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 9 Apr 2013
FDA classified: 21 Jan 2014
Reported: 29 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

9 Apr 2013	Recall initiated by company
21 Jan 2014	Classified by FDA	+287 days
29 Jan 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cartridges may contain individual discs which were not impregnated with antibiotic.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes

Where it was distributed

Nationwide Distribution: US including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B recalled?

Yes. Remel recalled Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B on 9 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-0794-2014.

Why was it recalled?

Cartridges may contain individual discs which were not impregnated with antibiotic.

Which lots are affected?

Lot 1215912, Exp. 31Jul2015

Where was it sold?

Nationwide Distribution: US including Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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