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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 Recall
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures)
see related information
Date Posted August 01, 2014
Recall Status1 Terminated on September 30, 2014
Recall Number Z-2138-2014
Recall Event ID 68774
Premarket Notification
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. 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/
Manufacturer
Advandx Inc
400 Tradecenter
Ste 6990
Woburn, Massachusetts 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NXX and Original Applicant = ADVANDX, INC.
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