Recall Z-0808-2013 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
| Date | Feb 12, 2013 (initiated Aug 21, 2012) |
| Status | Terminated |
| Reason | The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012. |
| Quantity | 23 units |
| Distribution | US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI, |
| 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 |