Device product
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.
Z-0443-2016
Product summary
- Firm
- Remel Inc
- Event
- Event 72525
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58/5/50 discs/catridges/packs
- Official record key
device-enforcement:Z-0443-2016
Official wording
Reason: Antibiotic concentration may be insufficient which may result in incorrect test results.
Code information: Lot 1686823, expiry 30 June 2018
Distribution pattern: 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.
Derived failure modes
-
Unknown
Antibiotic concentration may be insufficient which may result in incorrect test results.