Recall Z-1743-2020— Carolina Liquid Chemistries Corp
Class II · Terminated
Class II FDA medical device recall by Carolina Liquid Chemistries Corp, initiated 2020-01-20, terminated 2021-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent. 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.
- Recalling firm
- Carolina Liquid Chemistries Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-20
- Terminated
- 2021-01-14
- Firm location
- Brea, CA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.