Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
FDA Recall Z-1774-2022 · Posted None
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Recalling FirmAssociates of Cape Cod, Inc.
Recall StatusTerminated
Product CodeNQZ
Date Initiated2022-08-17
Date Terminated2024-06-12
Product Quantity243 kits
Reason for Recall
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Firm 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 [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].
Root Cause
Employee error
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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