|
Class 2 Device Recall Oxoid Antimicrobial Susceptibility Test Discs |
|
Date Initiated by Firm |
August 21, 2012 |
Date Posted |
February 06, 2013 |
Recall Status1 |
Terminated 3 on June 04, 2013 |
Recall Number |
Z-0790-2013 |
Recall Event ID |
63555 |
Product Classification |
Susceptibility test discs, antimicrobial - Product Code JTN
|
Product |
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, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam). |
Code Information |
Lot 1100699 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact |
Earleen C. Parks 913-888-0939
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 1-877-428-1922 or 1-913-895-4190. Customers with questions were instructed to call the Technical Support Department at 800-255-6730 (US) or 913-888-0939 (International).
For questions regarding this recall call 913-888-0939. |
Quantity in Commerce |
30 |
Distribution |
Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|