Z-1329-2019Class II

Fungitell Kit, Catalog FT001 -

Name: Z-1329-2019 Fungitell Kit, Catalog FT001 -
Creator: Associates of Cape Cod, Inc.
Published: 2018-12-19
License: https://open.fda.gov/license/

Associates of Cape Cod, Inc. / initiated 2018-12-19 / Terminated

FDA source

Associates of Cape Cod, Inc. began a recall of 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... on 2018-12-19. FDA classified it as Class II and gives the reason as "The kits may contain the incorrect number of components or the kits may be missing components". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1329-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-05-14
Terminated: 2020-05-12
Recalling firm: Associates of Cape Cod, Inc.
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.
Product code: NQZ Antigen, Invasive Fungal Pathogens
Reason for recall: The kits may contain the incorrect number of components or the kits may be missing components.
FDA root cause: Mixed-up of materials/components
Action: Important Message to Customers Concerning Fungitell Kit Configuration letters dated 12/19/18 were sent to customers.
Quantity in commerce: 795
Distribution: Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m
Product codes and lots: Lot FK18005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1329-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-14

Product code NQZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)