Fungitell STAT IVD Assay affected by incorrect printed reconstitution instructions
Associates of Cape Cod is recalling Fungitell STAT IVD Assay kits due to incorrect printed information on clamshells regarding reconstitution and pretreatment volumes. Users should verify procedures against official documentation before use.
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: This is an FDA Class II medical device recall involving incorrect printed information on product packaging. No illnesses or injuries have been reported. The hazard is potential for inaccurate test results if users follow the printed instructions, making this a labeling error without reported harm.
Plain-English summary
Associates of Cape Cod, Inc. is recalling Fungitell STAT IVD Assay for (1→3)-β-D-Glucan in Serum (Ref: FT007) in kit format. The recall affects 243 kits distributed worldwide, including in California and internationally to Austria, France, Germany, India, Ireland, Italy, Spain, and the United Kingdom.
The clamshells containing the Fungitell STAT Standard include incorrect printed information regarding the reconstitution and pretreatment volumes needed for the assay. Using incorrect volumes may result in inaccurate test results.
Users who have received affected lots (Lot #FK22008, Package Control #113041, Exp. Date 2023-11-21) should not rely solely on the printed instructions. Consult the correct procedural documentation from Associates of Cape Cod before performing the assay. Healthcare facilities and laboratories should verify their procedures immediately.
The recalled product
- Product
- Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
- Manufacturer
- Associates of Cape Cod, Inc.
- Affected units
- 243
Distribution
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