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U.S. Department of Health and Human Services

Class 2 Device Recall JAS Diagnostics Inc., SDI Biomed, Drew Scientific, and ETron Diagnostics

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  Class 2 Device Recall JAS Diagnostics Inc., SDI Biomed, Drew Scientific, and ETron Diagnostics see related information
Date Initiated by Firm April 07, 2014
Date Posted June 25, 2014
Recall Status1 Terminated 3 on August 21, 2014
Recall Number Z-1873-2014
Recall Event ID 68343
510(K)Number K011900  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

Code Information LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.  
Recalling Firm/
Manufacturer		 JAS Diagnostics Inc.
14100 Nw 57th Ct
Miami Lakes FL 33014-3107
For Additional Information Contact Lynne S. Broderick, PhD
305-324-2318
Manufacturer Reason
for Recall		 JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.
Quantity in Commerce 407
Distribution Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
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 = CGA and Original Applicant = JAS Diagnostics, Inc.
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