Recall Z-1743-2020 ยท DJG Enzyme Immunoassay, Opiates
Carolina Liquid Chemistries Corp
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
| Date | Jan 20, 2020 |
| Status | Terminated |
| Reason | 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 | 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 | 90 test kits/devices |
| Distribution | U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.