Home / Recalls / Advandx Inc / Z-2138-2014

Z-2138-2014 Class II Terminated

Recalled by Advandx Inc — Woburn, MA

Recall Details

Product Type
Devices
Report Date
August 13, 2014
Initiation Date
July 4, 2014
Termination Date
September 30, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 kits

Product Description

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)

Reason for Recall

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Distribution Pattern

Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.

Code Information

Lot Number: 04914 Exp. Date: 2015-06

Other recalls by Advandx Inc

  • Z-0619-2014 Class III — AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification (December 11, 2013)
  • Z-0112-2013 Class II — AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identificati (September 14, 2012)
  • Z-0116-2013 Class II — AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identificati (September 14, 2012)