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