Fentanyl Reagent Kit — Class II medical device recall Z-1743-2020
Terminated recall by Carolina Liquid Chemistries Corp, reported 2020-04-29, distributed in AZ, CA, FL, NC, NH, NJ, NY, TX. Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clini
| Recall number | Z-1743-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carolina Liquid Chemistries Corp, Brea, CA, United States |
| Recall initiated | 2020-01-20 |
| Classified | 2020-04-17 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-01-14 |
| Distributed | AZ, CA, FL, NC, NH, NJ, NY, TX |
| Quantity | 90 test |
| Reason classes | labeling |
| Lot numbers | C1942, D1945, H1801, H1901, H1933, L1909 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1743-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.