The Recall Desk
ModerateFDA (Devices)·Z-0734-2014·Announced 2014-01-22

Remel Recalls Oxoid Antimicrobial Susceptibility Testing Discs Due to Impregnation Defect

Remel Inc is recalling Oxoid Antimicrobial Susceptibility Testing Discs because individual discs may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a diagnostic tool that could lead to inaccurate test results, fitting the criteria for a moderate severity recall without reported injuries.

Plain-English summary

Remel Inc is recalling Oxoid Antimicrobial Susceptibility Testing Discs, MEM10, REF: CT0774B, 10 mcg meropenem. The product is packed in packs containing 5 cartridges per pack, with 50 discs per cartridge. The firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. The discs are 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.

The recall is being issued because individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes. The affected lot number is 1223566 with an expiration date of 8/31/2013. The quantity involved is 45 packs, 5 cartridges per pack, and 50 discs per cartridge.

The product was distributed nationwide, 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. Users should stop using the affected discs and contact Remel Inc for further instructions.

The recalled product

Product
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 t
Manufacturer
Remel Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number: 1223566 EXP: 8/31/2013

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically: