Reported Aug 13, 2014 · Terminated
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits…
Advandx Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advandx Inc · 400 Tradecenter · Woburn, MA · 01801
Is this the product you have?
- 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 numberQFFixBC1-50 (a component for QFSTABC1-50)
- Lot codes and dates
- Lot Number04914 Exp
- Date2015-06
- Amount recalled
- 10 kits
Where it was sold
Why it was recalled
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
This product could cause temporary or reversible health problems — stop using it.
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