Device 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)
Z-2138-2014
Product summary
- Firm
- Advandx Inc
- Event
- Event 68774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 kits
- Official record key
device-enforcement:Z-2138-2014
Official wording
Reason: Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Code information: Lot Number: 04914 Exp. Date: 2015-06
Distribution pattern: Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Derived failure modes
-
Unknown
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC