Fentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic
Carolina Liquid Chemistries Corp is recalling Fentanyl Reagent Kits sold to clinical labs without FDA clearance. The products were mislabeled for diagnostic use but are intended for forensic use only.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue is a labeling error regarding intended use (clinical vs. forensic) rather than a defect causing direct physical harm or contamination. No illnesses or injuries are reported, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Carolina Liquid Chemistries Corp is recalling 90 Fentanyl Reagent Kits (Product N. CC444) that were labeled for diagnostic use and sold to clinical laboratories without an FDA 510(k) clearance. The kits contain FENT R1 Reagent and FENT R2 Reagent. The affected lots are H1801, C1942, D1945, H1901, H1933, and L1909.
The recall was initiated because the products were marketed for clinical diagnostic purposes despite not being FDA cleared for such use. The firm has corrected the labeling to remove clinical diagnostic language and has notified customers that the products are labeled for "Forensic Use Only" and should not be used for clinical purposes.
The affected products were distributed in North Carolina, Texas, Florida, New York, Arizona, New Jersey, New Hampshire, and California. Clinical laboratories that purchased these kits should stop using them for diagnostic testing and contact the manufacturer for further instructions.
The recalled product
- Product
- Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
- Manufacturer
- Carolina Liquid Chemistries Corp
- Hazard
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots: H1801
- C1942
- D1945
- H1901
- H1933
- L1909
Distribution
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