Associates of Cape Cod, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1774-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 17, 2022

Date Posted: September 28, 2022

Recall Number: Z-1774-2022

Event ID: 90820

Reason for Recall:

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

Status: Terminated

Product Quantity: 243 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated