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U.S. Department of Health and Human Services

Class 2 Device Recall ACCI

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 Class 2 Device Recall ACCIsee related information
Date Initiated by FirmAugust 17, 2022
Create DateSeptember 20, 2022
Recall Status1 Terminated 3 on June 12, 2024
Recall NumberZ-1774-2022
Recall Event ID 90820
510(K)NumberK191167 
Product Classification Antigen, invasive fungal pathogens - Product Code NQZ
ProductFungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
Code Information UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
FEI Number 1219145
Recalling Firm/
Manufacturer		 Associates of Cape Cod, Inc.
124 Bernard E Saint Jean Drive
East Falmouth MA 02536-4445
For Additional Information ContactSAME
508-540-3444
Manufacturer Reason
for Recall		Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
FDA Determined
Cause 2		Employee error
ActionAssociates 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 in Commerce243 kits
DistributionWorldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
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.
510(K) Database510(K)s with Product Code = NQZ
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