Remel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs
Remel Inc is recalling specific lots of Gentamicin Antimicrobial Susceptibility Testing Discs because the antibiotic concentration may be insufficient, potentially leading to incorrect test results.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect could lead to significant clinical consequences such as incorrect treatment decisions.
Plain-English summary
Remel Inc is voluntarily recalling Lot 1686823 of Oxoid Gentamicin Antimicrobial Susceptibility Testing Discs (CN10), REF# CT0024B. The product is packaged in packs of 5 cartridges, with 50 discs per cartridge. The recall involves 58 packs, totaling 290 cartridges and 14,500 discs.
The FDA classified this as a Class II recall because the antibiotic concentration in the discs may be insufficient. This defect may result in incorrect in vitro susceptibility test results, which are used to assist in determining a suitable antibiotic agent for treatment purposes.
The affected product was distributed nationwide, including to Illinois, Georgia, Florida, North Carolina, California, Alabama, Massachusetts, Indiana, Missouri, New York, Texas, Virginia, Kansas, and Iowa, as well as Puerto Rico. The discs have an expiration date of 30 June 2018. Users should stop using the affected product and contact Remel Inc for further instructions.
The recalled product
- Product
- Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable…
- Manufacturer
- Remel Inc
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 (2)
- Lot 1686823
- expiry 30 June 2018
Distribution
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