Biocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue
Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 because a stability issue in the buffer prevents the chromogen from developing.
What this means for you
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, and the hazard involves a product failure (chromogen not developing) rather than a direct physical or biological injury risk to patients.
Plain-English summary
Biocare Medical, LLC is recalling Vulcan Fast Red Chromogen Kit 2, which is used in immunohistochemistry (IHC) procedures with an alkaline phosphatase (AP) detection system. The affected products are identified by catalog numbers FR805-5L and FR805S, and lot numbers 011818 and 022818.
The recall is due to a stability issue caused by environmental factors affecting a raw material in the Vulcan Fast Red Buffer. This issue results in the chromogen failing to develop. A total of 43 units were distributed to locations in California, Vermont, Kentucky, Louisiana, Oregon, Rhode Island, Georgia, Illinois, Massachusetts, Texas, Kansas, Florida, Japan, and Germany.
This is an FDA Class II recall. Users should stop using the affected kits and contact Biocare Medical for further instructions.
The recalled product
- Product
- Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
- Manufacturer
- Biocare Medical, LLC
- Hazard
- Affected units
- 43
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 numbers 011818 and 022818
Distribution
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