Reported Jun 15, 2016 · Terminated

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is…

Integrated Science Systems 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: Integrated Science Systems Inc · 1215 George C Wilson Dr Unit A4 · Augusta, GA · 30909-5700

Is this the product you have?

  • Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
Lot codes and dates
    • Lot Numbers - KJ05016
    • KJ05017
    • KJ05018
    • KJ06019
    • KJ06020
    • KJ06021
    • KJ07023
    • KJ10028
    • J06022
    • KJ07024
    • KJ07025
    • KJ09026
    • KJ09027
    • KJ10029
    • KJ10030
    • KJ11034
    • KJ11035
    • KJ12040
    • KJ12041
    • KJ12042
    • KJ12043
Amount recalled
2625 kits

Where it was sold

  • Nationwide
  • CA

Why it was recalled

Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

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 Feb 28, 2017 · Data as of Sep 19, 4:45 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.