PlainRecalls
FDA Devices Moderate Class II Terminated

Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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: January 22, 2014 Initiated: November 21, 2013 #Z-0734-2014

Product Description

Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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

Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

Details

Recalling Firm
Remel Inc
Units Affected
45/5/50 - discs/cartridges/packs
Distribution
Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV
Location
Lenexa, KS

Frequently Asked Questions

What product was recalled?
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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: 45/5/50 - discs/cartridges/packs.
Why was this product recalled?
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0734-2014.