Recall Z-0528-2014 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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 | Dec 17, 2013 (initiated Nov 21, 2012) |
| Status | Terminated |
| Reason | Boxes labeled as CIP5 may contain cartridges of AMP5. |
| Root cause | Mixed-up of materials/components |
| Action | Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any produc |
| Quantity | 60/5/50-disc cartridge boxes |
| Distribution | Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and 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 |