Fungitell Kit Recalled for Missing or Incorrect Components
Associates of Cape Cod, Inc. is recalling Fungitell Kits due to potential missing or incorrect components.
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, and the hazard involves missing components which is a functional defect rather than a direct physical injury risk like fire or choking, fitting the Moderate criteria for low-risk contamination or functional issues without reported injury.
Plain-English summary
Associates of Cape Cod, Inc. is recalling 795 units of the Fungitell Kit, Catalog FT001, Lot FK18005. The Fungitell assay is a colorimetric test used to detect (1-3)Beta-D Glucan in patient serum to aid in the diagnosis of invasive fungal infections.
The recall was initiated because the kits may contain the incorrect number of components or may be missing components entirely. This defect could affect the accuracy of the diagnostic results.
The affected products were distributed worldwide, including in the United States (California, Florida, Maryland, Utah, Virginia) and in Singapore, South Africa, and the United Kingdom. Users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal…
- Manufacturer
- Associates of Cape Cod, Inc.
- Affected units
- 795
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 FK18005
Distribution
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