medical Class II Updated 2020-04-29

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

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: NC, TX, FL, NY, AZ, NJ, NH, CA
Lot/Code Info: Lots: H1801, C1942, D1945, H1901, H1933, L1909
View official government recall

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