FDA Enforcement Class II Terminated

Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (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).

Recall: Z-0790-2013 · Reported February 13, 2013

Enforcement

Recall Number
Z-0790-2013
Event ID
63555
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Remel Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
February 13, 2013
Initiation Date
August 21, 2012
Classification Date
February 6, 2013
Termination Date
June 4, 2013
Address
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

Description

Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (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).

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.

Code Info

Lot 1100699

Distribution

Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.

Quantity

30