FDAJanuary 20, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

carolina liquid chemistriescarolinacarolina liquid

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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