Class II — Potential Health Hazard

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

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures) Recalled by Advandx Inc Due to Positive result in the Internal negative control well...

Date: July 4, 2014
Company: Advandx 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 Advandx Inc directly.

Affected Products

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 number: QFFixBC1-50 (a component for QFSTABC1-50)

Quantity: 10 kits

Why Was This Recalled?

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Where Was This Sold?

This product was distributed to 8 states: AZ, FL, ID, MI, MO, NJ, OH, VA

Affected (8 states)Not affected

About Advandx Inc

Advandx Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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