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Terminated

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.

FDA Recall Z-1329-2019 · Posted None

Recalling FirmAssociates of Cape Cod, Inc.
Recall StatusTerminated
Product CodeNQZ
Date Initiated2018-12-19
Date Terminated2020-05-12
Product Quantity795

Reason for Recall

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

Firm Action

Important Message to Customers Concerning Fungitell Kit Configuration letters dated 12/19/18 were sent to customers.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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