Recall Z-0443-2016 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
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.
| Date | Nov 6, 2015 |
| Status | Terminated |
| Reason | Antibiotic concentration may be insufficient which may result in incorrect test results. |
| Root cause | Nonconforming Material/Component |
| Action | ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated November 6, 2015, to all affected customers via first class mail. The recall notice identified the problem with the device and asked customers to inspect their stocks for the affected lots. The notice instructed customers to destroy any remaining inventory from the affected lots, contact the recalling firm for replacement, and complete the accompanying Acknowledgement form. Customers with questions were instructed to contact the Technical Services Departmentn at 800-255-6730 (US) or 913-888-0939 (International). For q |
| Quantity | 58/5/50 discs/catridges/packs |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860153 | OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS Oxoid U.S.A., Inc., Mar 4, 1986 |