East Falmouth, MA, United States
Associates of Cape Cod, Inc. recalls
2 recalls recorded since 2018, most recently on 17 August 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 17 August 2022
- Terminated
- 12 June 2024
- Reason
- Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1774-2022
- Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Terminated Class II Medical devices
- Recall started
- 19 December 2018
- Terminated
- 12 May 2020
- Reason
- The kits may contain the incorrect number of components or the kits may be missing components.
- Distribution
- Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1329-2019
- 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 con
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.