Device product
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.
Z-2081-2013
Product summary
- Firm
- Remel Inc
- Event
- Event 64852
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60 packs
- Official record key
device-enforcement:Z-2081-2013
Official wording
Reason: Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Code information: Lots 1194944 and 1198342
Distribution pattern: US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
Derived failure modes
-
Unknown
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.