Class 2 Device Recall The SPICE I Enzyme Immunoassay

• Date Initiated by Firm: February 10, 2020
• Create Date: April 10, 2020
• Recall Status: Terminated on January 14, 2021
• Recall Number: Z-1701-2020
• Recall Event ID: 85259
• Product Classification: Enzyme immunoassay, cannabinoids - Product Code LDJ
• Product: SPICE (JWH-018) CC443
• Code Information: Lots: D1906, D1939
• Recalling Firm/ Manufacturer: Carolina Liquid Chemistries Corp; 510 W Central Ave Ste C; Brea CA 92821-3032
• For Additional Information Contact: 714-529-1616
• Manufacturer Reason for Recall: Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.
• FDA Determined Cause: Other
• Action: On 01/20/2020, Immediate Action Required notices were emailed to Laboratory Directors 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
• Distribution: U.S.: NY, AL, CA, LA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.