Z-1743-2020 Class II Terminated
FDA device recall Z-1743-2020 was initiated by Carolina Liquid Chemistries Corp on January 20, 2020 and is designated Class II. 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 Us… The recall status is terminated (terminated January 14, 2021). Affected quantity: 90 test kits/devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- January 20, 2020
- Termination Date
- January 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 test kits/devices
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
Distribution Pattern
U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
Code Information
Lots: H1801, C1942, D1945, H1901, H1933, L1909