FDA recall Z-1743-2020

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-01-20

Report date

2020-04-29

Termination date

2021-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2020