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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NXX
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