Device 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 test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Z-0734-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 67099
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45/5/50 - discs/cartridges/packs
- Official record key
device-enforcement:Z-0734-2014
Official wording
Reason: Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
Code information: Lot number: 1223566 EXP: 8/31/2013
Distribution pattern: Nationwide Distribution 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
Derived failure modes
-
Unknown
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.