Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sure Vue Color Staph 150T Recalled by Integrated Science Systems Inc Due to Customer complaints of very weak reactions with the...

Date: February 19, 2016
Company: Integrated Science Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integrated Science Systems Inc directly.

Affected Products

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

Quantity: 2625 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integrated Science Systems Inc

Integrated Science Systems Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report