Home / Recalls / Associates of Cape Cod, Inc. / Z-1774-2022

Z-1774-2022 Class II Terminated

Recalled by Associates of Cape Cod, Inc. — East Falmouth, MA

Recall Details

Product Type: Devices
Report Date: September 28, 2022
Initiation Date: August 17, 2022
Termination Date: June 12, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 243 kits

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.

Code Information

UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21