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U.S. Department of Health and Human Services

Class 2 Device Recall HEMOCUE AB GLUCOSE 201 DM ANALYZER

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  Class 2 Device Recall HEMOCUE AB GLUCOSE 201 DM ANALYZER see related information
Date Initiated by Firm October 07, 2010
Date Posted March 30, 2011
Recall Status1 Terminated 3 on June 22, 2011
Recall Number Z-1848-2011
Recall Event ID 57602
510(K)Number K041230  
Product Classification in vitro diagnostic device for quantitative determination of blood glucose level. - Product Code CGA
Product HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.
Code Information Hb Glucose 201 DM System: (USA): Serial Numbers:  0632720008; 0651720088; 0641720017; 0651720037, 0651720087 & 0651720092; 0707720047; 0639720004; 0641720004, 0641720008,& 0641710015.  Hb Glucose 201 DM System: (Euroope): Serial Numbers:   064172009; 0641720032; 0641720042, 0641720044 & 0644720026 & 0644720050; 0644720006 & 0651720002; 0644720022; 0644720039, 0644720044 & 0651720006.  
Recalling Firm/
Manufacturer		 Hemo Cue, Inc.
11331 Valley View St
Cypress CA 90630-5366
For Additional Information Contact Allen M. White
562-668-5692
Manufacturer Reason
for Recall		 Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.
FDA Determined
Cause 2		 Process control
Action Hemocue AB sent Customer Notification "Notice of Medical Device Correction on HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers" dated October 7, 2010, to customers notifying them of incorrect settings on error codes. The corrective action consists of an update of the configuration settings on the the affected HemoCue Glucose 201 DM and Hb 201 DM analyzers that are in the field. The affected units in the field will be corrected in accordance with a rework procedure that has been established by HemoCue AB.
Quantity in Commerce 23
Distribution Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.
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 = HEMOCUE, INC.
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