FDA Medical Device Recalls (openFDA)
Associates of Cape Cod, Inc.: Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
- Recall number
- Z-1774-2022
- Recalling firm
- Associates of Cape Cod, Inc.
- Product
- Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
- Status
- Terminated
- Initiated
- 2022-08-17
- Posted
- not on file
- Terminated
- 2024-06-12
- Reason
- Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 243 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
- Lot, serial or model codes
- UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
- 510(k) numbers
- ["K191167"]
- PMA numbers
- not on file
- Product code
- NQZ
- Firm FEI
- 1219145
- Firm city
- Falmouth
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28