Carolina Liquid Chemistries Corp Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Brand
Carolina Liquid Chemistries Corp
Lot Codes / Batch Numbers
Lots: H1801, C1942, D1945, H1901, H1933, L1909
Products Sold
Lots: H1801, C1942, D1945, H1901, H1933, L1909
Carolina Liquid Chemistries Corp is recalling Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent due to Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified cu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, NH, NJ, NY, NC, TX
Page updated: Jan 10, 2026