Carolina Liquid Chemistries Corp recalls Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

Recall date

January 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1743-2020

FDA classification

Class II

Brand / firm

Carolina Liquid Chemistries Corp

Sold / distributed

U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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