Device product
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Z-1774-2022
Product summary
- Event
- Event 90820
- Status
- Terminated
- Classification
- Class II
- Quantity
- 243 kits
- Official record key
device-enforcement:Z-1774-2022
Official wording
Reason: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
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.
Derived failure modes
-
Unknown
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes