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Advandx Inc recalls AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are
Recalled August 13, 2014 · FDA recall Z-2138-2014 · Advandx
Hazard
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC · FDA Class II
Units
10 kits
Sold at
Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Description
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
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)
Manufacturer(s)
Advandx Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →