# FDA recall Z-1743-2020

> **Carolina Liquid Chemistries Corp** · Class II · device recall initiated 2020-01-20.

## Product

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

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-1743-2020
- **Recalling firm:** Carolina Liquid Chemistries Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-20
- **Report date:** 2020-04-29
- **Termination date:** 2021-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2020

## Citation

> AI Analytics. FDA recall Z-1743-2020. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-1743-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*