Recall Z-0793-2014 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, 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.
| Date | Jan 21, 2014 (initiated Apr 9, 2013) |
| Status | Terminated |
| Reason | Cartridges may contain individual discs which were not impregnated with antibiotic. |
| Root cause | Process design |
| Action | ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International). For questio |
| Quantity | 10 packs |
| Distribution | Nationwide Distribution: US including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964491 | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd., Feb 7, 1997 |