FDAFDA · Food and drugs·Recall number Z-2138-2014
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)
Published August 13, 2014 · Recall initiated: July 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Advandx Inc
- Distributor
- Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
- Lot
- Lot Number: 04914 Exp. Date: 2015-06
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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