Class 2 Device Recall Fentanyl Reagent Kit

• Date Initiated by Firm: January 20, 2020
• Create Date: April 17, 2020
• Recall Status: Terminated on January 14, 2021
• Recall Number: Z-1743-2020
• Recall Event ID: 85229
• Product Classification: Enzyme immunoassay, opiates - Product Code DJG
• Product: Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
• Code Information: Lots: H1801, C1942, D1945, H1901, H1933, L1909
• Recalling Firm/ Manufacturer: Carolina Liquid Chemistries Corp; 510 W Central Ave Ste C; Brea CA 92821-3032
• For Additional Information Contact: Allison Nestor; 877-722-8910 Ext. 135
• Manufacturer 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
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.