Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum recallZ-1774-2022 · Associates of Cape Cod, Inc. · initiated Aug 17, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Associates of Cape Cod, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
FDA root cause category: Employee error
What the company is doing
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 [email protected] 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, [email protected].
Recall details
- Recall number
- Z-1774-2022
- Status
- Terminated
- Initiated by the company
- Aug 17, 2022
- Recalling firm
- Associates of Cape Cod, Inc.
- Quantity
- 243 kits
- Product code
- NQZ
- FDA submissions
- K191167
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
Product description
Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
Code information (models, lots, serial numbers)
UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fungitell STAT 1Associates Of Cape Cod, Inc.1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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