FDA Medical Device Recalls (openFDA)
Carolina Liquid Chemistries Corp: Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
- Recall number
- Z-1743-2020
- Recalling firm
- Carolina Liquid Chemistries Corp
- Product
- Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
- Status
- Terminated
- Initiated
- 2020-01-20
- Posted
- not on file
- Terminated
- 2021-01-14
- 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
- Lot, serial or model codes
- Lots: H1801, C1942, D1945, H1901, H1933, L1909
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DJG
- Firm FEI
- 3000215862
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28