Z-1329-2019 Class II Terminated
FDA device recall Z-1329-2019 was initiated by Associates of Cape Cod, Inc. on December 19, 2018 and is designated Class II. Reason for recall: The kits may contain the incorrect number of components or the kits may be missing components. The recall status is terminated (terminated May 12, 2020). Affected quantity: 795.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- December 19, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 795
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.
Distribution Pattern
Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m
Code Information
Lot FK18005