FDA Device recall Z-1743-2020
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent by Carolina Liquid Chemistries, citing 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 labe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1743-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-20 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carolina Liquid Chemistries |
| Distribution | AZ, CA, FL, NC, NH, NJ, NY, TX |
Product
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Reason
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
Identifiers
| code_info | Lots: H1801, C1942, D1945, H1901, H1933, L1909 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1743-2020%22
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