Carolina Liquid Chemistries recalls Fentanyl Reagent Kit (Product N. CC444) for forensic use only, not clinical diagnostics. Products sold without FDA clearance may pose risks if misused.
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
Carolina Liquid Chemistries has recalled a Fentanyl Reagent Kit (Product N. CC444) because it was sold to clinical labs without proper FDA clearance. The products are now labeled for forensic use only and should not be used for clinical purposes.
The reagent kit was initially sold to clinical labs without FDA clearance, which could lead to misuse if used for diagnostic purposes. The manufacturer corrected the labeling to specify "Forensic Use Only" to prevent clinical use.
Clinical labs that purchased the Fentanyl Reagent Kit (Product N. CC444) without FDA clearance are affected. Forensic users who follow the "Forensic Use Only" labeling are at minimal risk.
Check for the product name "Fentanyl Reagent Kit" and product number CC444. The kit contains FENT R1 and FENT R2 reagents and was sold in specific lots: H1801, C1942, D1945, H1901, H1933, L1909.
Look for the label "Forensic Use Only" to confirm it is not for clinical purposes.
No, the product is labeled for forensic use only and not FDA cleared for clinical purposes.
The manufacturer has corrected the labeling to specify "Forensic Use Only" and does not require immediate action beyond checking the label.
The product was initially sold to clinical labs without FDA clearance and was corrected to label it for forensic use only.
We’ve drafted a message you can send Carolina Liquid Chemistries to request your refund or repair — edit it as you like.
Subject: Recall Z-1743-2020 — Carolina Liquid Chemistries Carolina Liquid Chemistries Hello, I own a Carolina Liquid Chemistries that is covered by recall Z-1743-2020 from Carolina Liquid Chemistries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
