Fungitell STAT Assay (Associates of Cape Cod) – Labeling Error (2022)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
Brand
Associates of Cape Cod, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
Products Sold
UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
Associates of Cape Cod, Inc. is recalling Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007 due to Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Recommended Action
Per FDA guidance
Associates of Cape Cod, Inc., issued Urgent Device Correction letter via Email to each distributor or customer on 8/17/22 US and outside the US on 8/18/22. Letter states reason for recall, health risk and action to take: Actions required from you: 1. Immediately discontinue the use of the Fungitell STAT Lot # FK22008 and Package Control # 113041. 2. Please complete the attached Acknowledgement of Notification form. a. Include the total number of unused FK22008 kits still in your inventory on the form. b. Coordinate the return of all unused FK22008 kits following the instructions on the form The completed form should be forwarded to custservice@acciusa.com 3. Please let us know if an adverse event (other than delayed testing) was associated with the recalled product. If you have any questions or concerns, please contact m: Josee Roy, Ph.D., Director, Product Development & Person Responsible for Medical Device Regulatory Compliance (508) 685-8249, jroy@acciusa.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026