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U.S. Department of Health and Human Services

Class 3 Device Recall ETHA RGT. KIT

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  Class 3 Device Recall ETHA RGT. KIT see related information
Date Initiated by Firm January 16, 2019
Create Date May 02, 2019
Recall Status1 Terminated 3 on February 02, 2021
Recall Number Z-1253-2019
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 11687
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
Manufacturer Reason
for Recall		 Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
FDA Determined
Cause 2		 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 20 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 and Original Applicant = Lin-Zhi International, Inc.
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