Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1743-2020 — Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

U.S. FDA — Device Enforcement · United States · 2020-01-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1743-2020
Date of alert
2020-01-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Carolina Liquid Chemistries Corp
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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