Hardy Diagnostics Recalls HardyCHROM SS Agar Due to Color Development Issue
Hardy Diagnostics is recalling HardyCHROM SS Agar (Lot 15037) due to a report of possible lack of color development in Shigella organisms.
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, which typically indicates a temporary or medically reversible adverse health consequence. The specific issue is a potential lack of color development, which is a functional defect in a diagnostic tool rather than a direct physical hazard like injury or death, fitting the Moderate category for low-risk contamination or functional issues without reported harm.
Plain-English summary
Hardy Diagnostics is recalling HardyCHROM SS Agar, catalog number G327, lot number 15037. The product is a selective chromogenic medium used for the primary screening isolation and differentiation of Salmonella and Shigella species.
The recall was initiated due to a report of possible lack of color development in Shigella organisms in the referenced lot. This issue may affect the accuracy of the diagnostic results for the specific lot.
The affected product was distributed worldwide, including in the United States (specifically Texas, California, Arizona, Washington, Puerto Rico, and Iowa), Canada, and New South Wales. Users of this product should stop using the affected lot and contact the manufacturer for further instructions.
The recalled product
- Product
- Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening…
- Manufacturer
- Hardy Diagnostics
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 no. 15037
- Expires: 00-00-2000
Distribution
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