Z-1743-2020Class II

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

Name: Z-1743-2020 Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Creator: Carolina Liquid Chemistries Corp
Published: 2020-01-20
License: https://open.fda.gov/license/

Carolina Liquid Chemistries / initiated 2020-01-20 / Terminated / root cause: labeling and UDI

FDA source

Carolina Liquid Chemistries Corp began a recall of Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent on 2020-01-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1743-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-20
Posted: 2020-04-17
Terminated: 2021-01-14
Recalling firm: Carolina Liquid Chemistries
Product: Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Product code: DJG Enzyme Immunoassay, Opiates
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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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
Quantity in commerce: 90 test kits/devices
Distribution: U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
Product codes and lots: Lots: H1801, C1942, D1945, H1901, H1933, L1909

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1743-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1743-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code DJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)