Product Wiki · Recalls · U.S. FDA — Device Enforcement

Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD… — recall Z-0790-2013

U.S. FDA — Device Enforcement · United States · 2012-08-21 · Class II

As described by U.S. FDA — Device Enforcement: 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-impreg

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0790-2013
Date of alert
2012-08-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Remel Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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