Device product
Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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-0795-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 65184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 packs
- Official record key
device-enforcement:Z-0795-2014
Official wording
Reason: Cartridges may contain individual discs which were not impregnated with antibiotic.
Code information: Lot 1227786, Exp. 31AUG2013
Distribution pattern: Nationwide Distribution: US including Puerto Rico.
Derived failure modes
-
Unknown
Cartridges may contain individual discs which were not impregnated with antibiotic.