Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Ethyl Alcohol Enzymatic Assay

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Ethyl Alcohol Enzymatic Assaysee related information
Date Initiated by FirmJanuary 11, 2019
Create DateMay 03, 2019
Recall Status1 Terminated 3 on March 22, 2021
Recall NumberZ-1256-2019
Recall Event ID 82011
510(K)NumberK032461 
Product Classification Alcohol dehydrogenase, specific reagent for ethanol enzyme method - Product Code DIC
ProductEthyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
Code Information (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025
Recalling Firm/
Manufacturer		 Lin-Zhi International Inc
2945 Oakmead Village Ct
Santa Clara CA 95051-0812
For Additional Information ContactBernice Lin
480-970-8811
Manufacturer Reason
for Recall		Shelf life of the product may be reduced due to degradation of the assay.
FDA Determined
Cause 2		Material/Component Contamination
ActionLin-Zhi International initiated the recall by email to its distributors on 01/11/2019. The letter identified the affected product, problem and actions to be taken. The distributors were directed to notify their customers and requested the destruction of the recalled product. For questions call T: ( 408) 970-8811 E: regulatory@lin-zhi.com
Quantity in Commerce49 kits
DistributionUS Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DIC
-
-