Z-0790-2013Class II

Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK...

Name: Z-0790-2013 Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK...
Creator: Remel Inc
Published: 2012-08-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2012-08-21 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of... on 2012-08-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0790-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-21
Posted: 2013-02-06
Terminated: 2013-06-04
Recalling firm: Remel Inc
Product: 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).
Product code: JTN Susceptibility Test Discs, Antimicrobial
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lot 1100699

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0790-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0790-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-06

Product code JTN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-06. View this recall on fda.gov (opens on fda.gov)