FDA-Device2013-09-04Class III

Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

Remel Inc
Hazard

Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

Sold states
US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
Affected count
60 packs
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2081-2013

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