FDAClass IIDecember 23, 2015

Oxoid Gentamicin Antimicrobial Susceptibility Testing recall

Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. 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.

Why was Oxoid Gentamicin Antimicrobial Susceptibility Testing recalled?

Antibiotic concentration may be insufficient which may result in incorrect test results.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 1686823, expiry 30 June 2018

Product
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. 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.
Recalling firm
Remel Inc
Quantity
58/5/50 discs/catridges/packs
Distribution
Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.
Recall date
December 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls