Recall Z-1911-2016— Integrated Science Systems Inc
Class II · Terminated
Class II FDA medical device recall by Integrated Science Systems Inc, initiated 2016-02-19, terminated 2017-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures..
- Recalling firm
- Integrated Science Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-19
- Terminated
- 2017-02-28
- Firm location
- Augusta, GA, United States
Product description
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
Reason for recall
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.