Remel Recalls Oxoid Aztreonam Antimicrobial Susceptibility Test Discs
Remel Inc is recalling Oxoid Aztreonam test discs because some may lack antibiotic impregnation, potentially affecting test accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a lack of impregnation leading to inaccurate test results rather than direct physical injury or contamination, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Remel Inc is recalling Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B. The recall is due to a quality control issue where some cartridges may contain individual discs that are not impregnated with the antibiotic Aztreonam.
The affected product is identified by Lot 1100699. These discs are used in laboratories to measure the in vitro susceptibility of bacterial pathogens to antimicrobial agents. The recall covers nationwide distribution, including shipments to Wisconsin, Missouri, Massachusetts, Connecticut, Alabama, Illinois, Washington, California, Rhode Island, Maryland, New Jersey, North Carolina, and Texas.
Remel Inc notified customers of the recall via letter and requested confirmation of receipt. Users of the product should stop using the affected lot and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Remel Inc
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1100699
Distribution
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