FDAFDA · Food and drugs·Recall number Z-1743-2020
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Published April 29, 2020 · Recall initiated: January 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Carolina Liquid Chemistries Corp
- Distributor
- U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
- Lot
- Lots: H1801, C1942, D1945, H1901, H1933, L1909
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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