PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 23, 2015 Initiated: November 6, 2015 #Z-0443-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Remel Inc
Units Affected
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.
Location
Lenexa, KS

Frequently Asked Questions

What product 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.. Recalled by Remel Inc. Units affected: 58/5/50 discs/catridges/packs.
Why was this product recalled?
Antibiotic concentration may be insufficient which may result in incorrect test results.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0443-2016.