Associates of Cape Cod, Inc. recalls Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the

Recalled May 22, 2019 · FDA recall Z-1329-2019 · Associates of Cape Cod

Hazard

The kits may contain the incorrect number of components or the kits may be missing components. · FDA Class II

Units

795

Sold at

Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m

Description

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

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.

Manufacturer(s)

Associates of Cape Cod, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →