Greensboro, NC, United States
Carolina Liquid Chemistries recalls
3 recalls recorded since 2018, most recently on 10 February 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 February 2020
- Terminated
- 14 January 2021
- Reason
- Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.
- Distribution
- U.S.: NY, AL, CA, LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1701-2020
Terminated Class II Medical devices
- Recall started
- 20 January 2020
- Terminated
- 14 January 2021
- 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
- Distribution
- U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1743-2020
- Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Terminated Class III Medical devices
- Recall started
- 16 January 2019
- Terminated
- 2 February 2021
- Reason
- Distribution
- NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1252-2019, Z-1253-2019
- CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.