medical Class II Updated 2019-05-22

Associates of Cape Cod, Inc. recalls Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell

Recalled 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 infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.


Hazard / Issue

The kits may contain the incorrect number of components or the kits may be missing components.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot FK18005
View official government recall

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