Recall Z-2138-2014— Advandx Inc
Class II · Terminated
Class II FDA medical device recall by Advandx Inc, initiated 2014-07-04, terminated 2014-09-30. It names one FDA 510(k) clearance: K113371. 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). Reason: Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC.
- Recalling firm
- Advandx Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-04
- Terminated
- 2014-09-30
- Firm location
- Woburn, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.