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
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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
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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 |
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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 = CGA
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