Recall Z-0790-2013 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, t
| Date | Feb 6, 2013 (initiated Aug 21, 2012) |
| Status | Terminated |
| Reason | The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt. |
| Root cause | Nonconforming Material/Component |
| Action | ThermoFisher sent an Important Medical Device Product Recall Notice dated August 17, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review results reported using this lot and consider restesting and/or seek approproiate expert advice. Customers were requested to destroy any remaining inventory of the affected lot and contact Customer Services or their local Oxoid supplier who will issue a replacement. Customer were asked to return the attached "Acknowledgement & Receipt Form by FAX to |
| Quantity | 30 |
| Distribution | Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.