Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colo...
FDA Recall #Z-1329-2019 — Class II — December 19, 2018
Product Description
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.
Reason for Recall
The kits may contain the incorrect number of components or the kits may be missing components.
Recalling Firm
Associates of Cape Cod, Inc. — East Falmouth, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
795
Distribution
Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m
Code Information
Lot FK18005
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated