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

Hazard

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

Details from the source

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: Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK. Quantity: 243 kits Lot/code info: UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21

UPC codes

00862696000227

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.