Z-1774-2022 Class II Terminated
FDA device recall Z-1774-2022 was initiated by Associates of Cape Cod, Inc. on August 17, 2022 and is designated Class II. Reason for recall: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes The recall status is terminated (terminated June 12, 2024). Affected quantity: 243 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- August 17, 2022
- Termination Date
- June 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 243 kits
Product Description
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 Pattern
Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
Code Information
UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21