Fungitell Kit — Class II medical device recall Z-1329-2019
Terminated recall by Associates of Cape Cod, Inc., reported 2019-05-22, distributed nationwide. The kits may contain the incorrect number of components or the kits may be missing components.
| Recall number | Z-1329-2019 |
|---|---|
| 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 | 2018-12-19 |
| Classified | 2019-05-14 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | SG, ZA |
| Quantity | 795 |
| Lot numbers | FK18005 |
| Model numbers | FT001 |
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 for recall
The kits may contain the incorrect number of components or the kits may be missing components.
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-1329-2019. 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.