Associates of Cape Cod, Inc. recalls Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

Recalled September 28, 2022 · FDA recall Z-1774-2022 · Associates of Cape Cod

Hazard

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

Units

243 kits

Sold at

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

Description

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

Product

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

Manufacturer(s)

Associates of Cape Cod, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →