Remel Inc recalls Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50…

Recall date

November 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0443-2016

FDA classification

Class II

Brand / firm

Remel Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.