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U.S. Department of Health and Human Services

Class 2 Device Recall Glucose Hexokinase (Liquid) Reagent

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  Class 2 Device Recall Glucose Hexokinase (Liquid) Reagent see related information
Date Initiated by Firm October 23, 2014
Date Posted December 18, 2014
Recall Status1 Terminated 3 on February 26, 2015
Recall Number Z-0827-2015
Recall Event ID 69622
510(K)Number K011900  
Product Classification Hexokinase, glucose - Product Code CFR
Product Glucose Hexokinase (Liquid) Reagent

For the in vitro quantitative determination of Glucose in serum.
Code Information Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.
Recalling Firm/
Manufacturer		 JAS Diagnostics Inc.
14100 Nw 57th Ct
Miami Lakes FL 33014-3107
For Additional Information Contact Lynne S. Broderick, PhD
305-418-2320
Manufacturer Reason
for Recall		 Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
FDA Determined
Cause 2		 Under Investigation by firm
Action On October 23, 2014, JAS Diagnostics, Inc. sent out an IMPORTANT PRODUCT RECALL INFORMATION letter asking its consignees to discontinue use of the Glucose Hexokinase lots immediately. Customers are to contact the Service Department at 305-748-2762 or 305-748-2763 for information regarding reimbursement. Also, customers are to complete the attached Certificate of Destruction and return the document to JAS Diagnostics.
Quantity in Commerce 390
Distribution Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.
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 = CFR and Original Applicant = JAS Diagnostics, Inc.
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