Recall Z-1246-2014 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. 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.
| Date | Mar 20, 2014 (initiated Feb 18, 2014) |
| Status | Terminated |
| Reason | Some of the discs may not be impregnated with the antibiotic. |
| Root cause | Process control |
| Action | ThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device |
| Quantity | 40/5/50-disc cartridge packages |
| Distribution | Nationwide Distribution |
| 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 |