Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com

FDA device recall Z-0790-2013 · posted 2013-02-06 · Terminated

Recall details

Recalling firm

Remel Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JTN

Quantity affected

30

Distribution

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

Date initiated

2012-08-21

Date posted

2013-02-06

Date terminated

2013-06-04

Location

Lenexa, KS