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U.S. Department of Health and Human Services

Class 2 Device Recall Fungitell Assay

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 Class 2 Device Recall Fungitell Assaysee related information
Date Initiated by FirmDecember 19, 2018
Create DateMay 14, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall NumberZ-1329-2019
Recall Event ID 82551
Product Classification Antigen, invasive fungal pathogens - Product Code NQZ
ProductFungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
Code Information Lot FK18005
FEI Number 1219145
Recalling Firm/
Manufacturer		 Associates of Cape Cod, Inc.
124 Bernard E Saint Jean
East Falmouth MA 02536-4445
For Additional Information Contact
508-540-3444
Manufacturer Reason
for Recall		The kits may contain the incorrect number of components or the kits may be missing components.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionImportant Message to Customers Concerning Fungitell Kit Configuration letters dated 12/19/18 were sent to customers.
Quantity in Commerce795
DistributionWorldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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