FDA recall Z-1774-2022

Product

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

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

Key facts

Status

Terminated

Initiation date

2022-08-17

Report date

2022-09-28

Termination date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Falmouth, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2022