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 | Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes |
| Product | Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007 |
| Quantity | 243 kits |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK. |
| Initiated | 2022-08-17 |
| Classified | 2022-09-20 |
| Terminated | 2024-06-12 |
| Recall number | Z-1774-2022 |
| 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-1774-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90820/
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