Recall Z-1774-2022— Associates of Cape Cod, Inc.

Name: FDA recall Z-1774-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-17

Class II · Terminated

Class II FDA medical device recall by Associates of Cape Cod, Inc., initiated 2022-08-17, terminated 2024-06-12. It names one FDA 510(k) clearance: K191167. 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

510(k) clearances named in this recall

1 on FDA's record

K191167 — Fungitell STATAssociates of Cape Cod, Inc.·cleared 2019-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.