Recall Z-2138-2014 ยท NXX Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Advandx Inc
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)
| Date | Aug 1, 2014 (initiated Jul 4, 2014) |
| Status | Terminated |
| Reason | Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC |
| Root cause | 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 | 10 kits |
| Distribution | Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113371 | STAPHYLOCOCCUS QUICKFISH BC Advandx, Inc., Apr 3, 2012 |