Recall Z-1329-2019— Associates of Cape Cod, Inc.
Class II · Terminated
Class II FDA medical device recall by Associates of Cape Cod, Inc., initiated 2018-12-19, terminated 2020-05-12. 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.. Reason: The kits may contain the incorrect number of components or the kits may be missing components..
- Recalling firm
- Associates of Cape Cod, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-19
- Terminated
- 2020-05-12
- Firm location
- East Falmouth, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.