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Terminated

Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

FDA Recall Z-1743-2020 · Posted None

Recalling FirmCarolina Liquid Chemistries Corp
Recall StatusTerminated
Product CodeDJG
Date Initiated2020-01-20
Date Terminated2021-01-14
Product Quantity90 test kits/devices

Reason for Recall

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

Firm Action

On 01/20/20 Immediate Action Required notifications were emailed to customers inquiring about the disposition of discontinued products; whether they had been used, if there was remaining inventory. Customers were asked to fill out and return the Immediate Action Required form. Customers were provided with the following contact information: 336-722-8910 and carolinachemistries.com

Root Cause

Labeling design

Distribution Pattern

U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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