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/ Manufacturer |
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.
|