Carolina Liquid Chemistries Corp: Medical Device Recall in 2020 - (Recall #: Z-1743-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 20, 2020

Date Posted: April 29, 2020

Recall Number: Z-1743-2020

Event ID: 85229

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

Status: Terminated

Product Quantity: 90 test kits/devices

Code Information:

Lots: H1801, C1942, D1945, H1901, H1933, L1909

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated