Recall Z-1774-2022— Associates of Cape Cod, Inc.
Class II · Terminated
Class II FDA medical device recall by Associates of Cape Cod, Inc., initiated 2022-08-17, terminated 2024-06-12. Product: Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007. Reason: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes.
- Recalling firm
- Associates of Cape Cod, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-08-17
- Terminated
- 2024-06-12
- Firm location
- East Falmouth, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.