Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Summary
The FDA issued a Class II for Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 by Associates of Cape Cod, Inc.. Reason: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and p.
Details
Source
Device Recall
External ID
Z-1774-2022
Action Date
2022-09-28
Status
Terminated
Category
device
Product Description
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Lot/Code Info: UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
Quantity Affected: 243 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
Distribution
Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-17
Company
East Falmouth, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Associates of Cape Cod, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Associates of Cape Cod, Inc. have FDA actions?
This is the only FDA action we have on record for Associates of Cape Cod, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1774-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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