Remel TB Potassium Permanganate Stain Recalled for Performance Issues
Remel Inc is recalling TB Potassium Permanganate stain due to potential cloudiness or discoloration that may affect mycobacterial diagnosis.
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 source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Remel Inc is recalling Remel TB Potassium Permanganate (.5% Aqueous) 40192, a stain used in qualitative procedures for the fluorescent microscopic detection of mycobacteria. The product is packaged in 250 ml bottles, with 5 bottles per package. The recall involves Lot 293086, which has an expiration date of April 1, 2015.
The recall was initiated because the product may appear cloudy or discolored and may not perform correctly in the presumptive diagnosis of mycobacterial disease. This defect could potentially impact the accuracy of diagnostic results.
The affected product was distributed worldwide to the United States, including Alabama, California, Colorado, Iowa, Missouri, North Carolina, New York, Nevada, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, and Wisconsin, as well as internationally to Canada. Users of the product should stop using the affected lot and contact Remel Inc for further instructions.
The recalled product
- Product
- Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
- 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 (1)
- Lot: 293086 Expiration 01Apr2015
Distribution
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