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Class 3 Device Recall ETHA RGT. KIT |
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Date Initiated by Firm |
January 16, 2019 |
Create Date |
May 02, 2019 |
Recall Status1 |
Terminated 3 on February 02, 2021 |
Recall Number |
Z-1252-2019 |
Recall Event ID |
82017 |
510(K)Number |
K032461
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Product Classification |
Alcohol dehydrogenase, specific reagent for ethanol enzyme method - Product Code DIC
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Product |
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 |
Code Information |
Lot 11686 |
Recalling Firm/ Manufacturer |
Carolina Liquid Chemistries 313 Gallimore Dairy Rd Greensboro NC 27409-9724
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For Additional Information Contact |
Allison Nestor 877-722-8910 Ext. 135
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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 |
14 kits |
Distribution |
NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DIC and Original Applicant = Lin-Zhi International, Inc.
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