Class II — Associates of Cape Cod, Inc.
| Recalling firm | ASSOCIATES OF CAPE COD, INC. |
|---|---|
| Registered facility | ASSOCIATES OF CAPE COD, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The kits may contain the incorrect number of components or the kits may be missing components. |
| 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 … |
| Quantity | 795 |
| Distribution | Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m |
| Initiated | 2018-12-19 |
| Classified | 2019-05-14 |
| Terminated | 2020-05-12 |
| Recall number | Z-1329-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Associates of Cape Cod, Inc. (Z-1329-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82551/
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