Recall Z-0734-2014 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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
| Date | Jan 14, 2014 (initiated Nov 21, 2013) |
| Status | Terminated |
| Reason | Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes. |
| Root cause | Unknown/Undetermined by firm |
| Action | Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the |
| Quantity | 45/5/50 - discs/cartridges/packs |
| Distribution | Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983718 | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., Dec 11, 1998 |