Fungitell STAT- IVD Assay for — Class II medical device recall Z-1774-2022
Terminated recall by Associates of Cape Cod, Inc., reported 2022-09-28, distributed nationwide. Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to prin
| Recall number | Z-1774-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Associates of Cape Cod, Inc., East Falmouth, MA, United States |
| Recall initiated | 2022-08-17 |
| Classified | 2022-09-20 |
| Reported by FDA | 2022-09-28 |
| Terminated | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, ES, FR, GB, IE, IN, IT |
| Quantity | 243 kits |
| UPC / GTIN / UDI-DI | 00862696000227 |
| Lot numbers | FK22008 |
| Model numbers | FT007 |
| Expiration dates | 2023-11-21 |
Product
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Reason for recall
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1774-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.