Recall Z-0619-2014 ยท JSS Kit, Identification, Enterobacteriaceae
AdvanDx, Inc.
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
| Date | Jan 2, 2014 (initiated Dec 11, 2013) |
| Status | Terminated |
| Reason | Kits incompatible with certain fluorescence microscope light sources |
| Root cause | Process design |
| Action | AdvanDx issued an email notification along with a PDF file of the new package insert to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or techwupport@advandx.com. For ques |
| Quantity | 49 kits US; 17 kits OUS |
| Distribution | Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123418 | GRAM-NEGATIVE QUICKFISH BC Advandx, Inc., Jul 21, 2013 |