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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 30, 2014 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.