Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 Recalled by Associates of Cape Cod, Inc. Due to Incorrect information on the Fungitell STAT clamshells containing...

Date: August 17, 2022
Company: Associates of Cape Cod, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Associates of Cape Cod, Inc. directly.

Affected Products

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

Quantity: 243 kits

Why Was This Recalled?

Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Associates of Cape Cod, Inc.

Associates of Cape Cod, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report