Recall Z-1743-2020
Carolina Liquid Chemistries Corp · initiated January 20, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Codes / lots: Lots: H1801, C1942, D1945, H1901, H1933, L1909
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 taken
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
Details
- Recall number
- Z-1743-2020
- Initiated
- January 20, 2020
- Terminated
- January 14, 2021
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Quantity
- 90 test kits/devices
- Distribution
- U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
- Recalling firm
- Carolina Liquid Chemistries Corp, Brea, CA