Reported May 22, 2019 · Terminated

Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the…

Associates of Cape Cod, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Associates of Cape Cod, Inc. · 124 Bernard E Saint Jean · East Falmouth, MA · 02536-4445

Fungitell Kit
Catalog FT001 - Product UsageThe 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

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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