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 - KJ05016KJ05017KJ05018KJ06019KJ06020KJ06021KJ07023KJ10028J06022KJ07024KJ07025KJ09026KJ09027KJ10029KJ10030KJ11034KJ11035KJ12040KJ12041KJ12042KJ12043
- 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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