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Carolina Liquid Chemistries Corp recalls Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Recalled April 29, 2020 · FDA recall Z-1743-2020 · Carolina Liquid Chemistries
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 · FDA Class II
Units
90 test kits/devices
Sold at
U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
Description
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
Product
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Manufacturer(s)
Carolina Liquid Chemistries Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →