Class 3 Device Recall ETHA RGT. KIT

• Date Initiated by Firm: January 16, 2019
• Create Date: May 02, 2019
• Recall Status: Terminated on February 02, 2021
• Recall Number: Z-1252-2019
• Recall Event ID: 82017
• 510(K)Number: K032461
• Product Classification: Alcohol dehydrogenase, specific reagent for ethanol enzyme method - Product Code DIC
• Product: CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
• Code Information: Lot 11686
• FEI Number: 3009880320
• Recalling Firm/ Manufacturer: Carolina Liquid Chemistries; 313 Gallimore Dairy Rd; Greensboro NC 27409-9724
• For Additional Information Contact: Allison Nestor; 877-722-8910 Ext. 135
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.
• Quantity in Commerce: 14 kits
• Distribution: NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
• 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.

• 510(K) Database: 510(K)s with Product Code = DIC