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U.S. Department of Health and Human Services

Class 2 Device Recall AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures)

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  Class 2 Device Recall AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures) see related information
Date Initiated by Firm July 04, 2014
Date Posted August 01, 2014
Recall Status1 Terminated 3 on September 30, 2014
Recall Number Z-2138-2014
Recall Event ID 68774
510(K)Number K113371  
Product Classification Fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus - Product Code NXX
Product AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test
Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Code Information Lot Number: 04914 Exp. Date: 2015-06
Recalling Firm/
Advandx Inc
400 Tradecenter
Ste 6990
Woburn MA 01801
Manufacturer Reason
for Recall
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
FDA Determined
Cause 2
Nonconforming Material/Component
Action AdvanDx notified customers by e-mail on July 4, 2014 of the problem and advised to discontinue use of the QuickFISH Fixation Kits with Lot#04914. Replacement kits were immediately shipped to all of the affected customers. Questions contact local AdvanDx representative or Technical Support 1-866-376-0009, fax 1-781-376-0111 or e-mail: techsupport@advandx.com. An acknowledgement of Receipt and Destruction of Materials requested to be completed.
Quantity in Commerce 10 kits
Distribution Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NXX and Original Applicant = ADVANDX, INC.