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

Recall Insight

This FDA Devices action (record #Z-1743-2020) was formally reported on April 29, 2020, with the manufacturer initiating the action on January 20, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Carolina Liquid Chemistries Corp is listed as the recalling firm, operating out of Brea, CA. Federal records indicate 90 test kits/devices units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.