Recall Z-2081-2013 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
| Date | Aug 26, 2013 (initiated Mar 25, 2013) |
| Status | Terminated |
| Reason | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. |
| Root cause | Unknown/Undetermined by firm |
| Action | ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at |
| Quantity | 60 packs |
| Distribution | US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA. |
| 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 |