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Recall Observatory FDA recall evidence

Device 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.

Z-1329-2019

December 19, 2018

Class II

Product summary

Firm
Associates of Cape Cod, Inc.
Event
Event 82551
Status
Terminated
Classification
Class II
Quantity
795
Official record key
device-enforcement:Z-1329-2019

Official wording

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

Code information: Lot FK18005

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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