Z-1774-2022Class II

Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

Name: Z-1774-2022 Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
Creator: Associates of Cape Cod, Inc.
Published: 2022-08-17
License: https://open.fda.gov/license/

Associates of Cape Cod, Inc. / initiated 2022-08-17 / Terminated / root cause: manufacturing process

FDA source

Associates of Cape Cod, Inc. began a recall of Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007 on 2022-08-17. FDA classified it as Class II and gives the reason as "Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1774-2022
Classification: Class II
Status: Terminated
Initiated: 2022-08-17
Posted: 2022-09-20
Terminated: 2024-06-12
Recalling firm: Associates of Cape Cod, Inc.
Product: Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
Product code: NQZ Antigen, Invasive Fungal Pathogens
Reason for recall: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Associates of Cape Cod, Inc., issued Urgent Device Correction letter via Email to each distributor or customer on 8/17/22 US and outside the US on 8/18/22. Letter states reason for recall, health risk and action to take: Actions required from you: 1. Immediately discontinue the use of the Fungitell STAT Lot # FK22008 and Package Control # 113041. 2. Please complete the attached Acknowledgement of Notification form. a. Include the total number of unused FK22008 kits still in your inventory on the form. b. Coordinate the return of all unused FK22008 kits following the instructions on the form The completed form should be forwarded to [email protected] 3. Please let us know if an adverse event (other than delayed testing) was associated with the recalled product. If you have any questions or concerns, please contact m: Josee Roy, Ph.D., Director, Product Development & Person Responsible for Medical Device Regulatory Compliance (508) 685-8249, [email protected].
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1774-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1774-2022	Class II	Terminated	Voluntary: Firm initiated	2022-09-28	2022-09-20

Product code NQZ

K191167Class IIFungitell STATAssociates of Cape Cod, Inc. / cleared 2019-07-17

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)