Advandx Inc Recalls
Showing 1-3 of 3 recalls
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)
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
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.
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. co
Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal
AdvanDx notified customers on September 14, 2012 by email along with a PDF file of the new package insert to each contact followed by written notification and a paper copy of the new package insert via FedEx courier. The notification described the product, problem and actions to be taken. The customers were instructed to destroy the package insert in any existing inventory of the kit and replace it with the enclosed package insert. "Note: All shipments of E. coli/P.aeruginosa PNA FISH as of September 14, 2012, will contain this new package insert." The customers were also instructed to complete and return the Acknowledgement of Receipt form to AdvanDX: Regulatory Affairs; 400 TradeCenter, Suite 6990, Woburn, MA 01801-7476; Fax to: +1 (781) 376-0111; bsc@advandx.com. If you have any questions or requests for further information, please contact AdvanDx Technical Support: US (Toll-Free): 1-866-376-0009, techsupport@advandx.com.
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing o
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
AdvanDx sent a "GNR Traffic Light PNA FISH (KT011) Package Insert Replacement" letter dated September 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received an Acknowledgement Form to complete and return to AdvanDx so that the effectiveness of the replacement can be evaluated. Contact AdvanDx Technical Support at 1-866-376-0009 for questions regarding this notice.