Class II — Potential Health Hazard

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

Fentanyl Reagent Kit Recalled by Carolina Liquid Chemistries Corp Due to Labeled for diagnostic use and sold to clinical...

Date: January 20, 2020
Company: Carolina Liquid Chemistries Corp
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 Carolina Liquid Chemistries Corp directly.

Affected Products

Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

Quantity: 90 test kits/devices

Why Was This Recalled?

Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes

Where Was This Sold?

This product was distributed to 8 states: AZ, CA, FL, NH, NJ, NY, NC, TX

Affected (8 states)Not affected

About Carolina Liquid Chemistries Corp

Carolina Liquid Chemistries Corp has 2 total recalls tracked by RecallDetector.

Related Recalls

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