| Class 2 Device Recall HemoCue Glucose 201 Microcuvettes |  |
Date Initiated by Firm | October 20, 2014 |
Date Posted | December 24, 2014 |
Recall Status1 |
Terminated 3 on October 02, 2015 |
Recall Number | Z-0873-2015 |
Recall Event ID |
69663 |
510(K)Number | K020935 |
Product Classification |
Glucose oxidase, glucose - Product Code CGA
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Product | HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.
Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257.
HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. |
Code Information |
Model Number 110705: Lot numbers: 1310500, 1310501, 1310502, 1310503, 1310518, 1310519, 1310520, 1310521, 1310767, 1310768, 1310769, 1310770, 1310771, 1310772, 1310779, 1310780, 1310781, 1310788, 1310789, 1310790, 1310799, 1311524, 1311525, 1311526, 1311527, 1311528, 1311529, 1311530, 1311531, 1311532, 1311533, 1311534, 1311535, 1311536, 1311537, 1311538, 1311539, 1311541, 1311542 Model Number 110706: Lot numbers: 1310207, 1310208, 1310209, 1310210, 1310211, 1310212, 1310213, 1310214, 1310215, 1310216, 1310228, 1310231, 1310232, 1310234, 1310235, 1310238, 1310239, 1310247, 1310249, 1310250, 1310256, 1310257, 1310258, 1310259, 1310260, 1311270, 1311271, 1311272, 1311273, 1311274, 1311279, 1311280, 1311281, 1311282, 1311283, 1311284, 1311291, 1311296, 1311297, 1311314, 1311315, 1311316, 1311317, 1311318, Model Number 110715: Lot numbers: 1310217, 1310218, 1310219, 1310221, 1310222, 1310229, 1310230, 1310237, 1310240, 1310241, 1310242, 1310251, 1310252, 1311267, 1311268, 1311269, 1311298, 1311301, 1311302, 1311303, 1311304, 1311321, 1311322, 1311323, 1311324 Model Number 110716: Lot numbers: 1310202, 1310203, 1310204, 1310223, 1310224, 1310225, 1310227, 1310243, 1310244, 1310245, 1310246, 1310261, 1311263, 1311264, 1311265, 1311266, 1311277, 1311278, 1311305, 1311306, 1311307, 1311308, 1311309, 1311310, 1311311, 1311312, 1311313, 1311325 Model Number 110717: Lot numbers: 1310504, 1310505, 1310506, 1310507, 1310508, 1310509, 1310510, 1310514, 1310515, 1310516, 1310517, 1310773, 1310774, 1310775, 1310776, 1310783, 1310784, 1310785, 1310791, 1310792, 1310794, 1310795, 1310796, 1311540, 1311543, 1311544, 1311545 Model Number 110718: Lot numbers: 1310511, 1310512, 1310513, 1310777, 1310778, 1310786, 1310787, 1310797, 1310798 Model Number 110719: Lot numbers: 1310236, 1310237, 1310248, 1311285, 1311286, 1311287, 1311288, 1311289, 1311290, 1311292, 1311293, 1311294, 1311295, 1311299, 1311300 Model Number 110720: Lot numbers: 1310205, 1310206, 1310226, 1310253, 1310254, 1310255, 1311319, 1311320 |
Recalling Firm/ Manufacturer |
Radiometer America Inc 810 Sharon Dr Westlake OH 44145-1521
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For Additional Information Contact | Matthew R. Ackerman 440-871-8900 Ext. 53485 |
Manufacturer Reason for Recall | Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months.
The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result.
HemoCue Glucose 201 Microcuvettes are for In Vitro Diag |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The consignees will be notified by a Field Safety Notice. Distributors will be instructed to forward the Field Safety Notice to their end customers and to secure that verification forms will be filled-out by end customers and returned to HemoCue. |
Quantity in Commerce | 3,712,900 microcuvettes |
Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Austria, AUSTRALIA, SWITZERLAND, COTE D'IVOIRE, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, FINLAND, FRANCE, UNITED KINGDOM, GEORGIA, HONG KONG, CROATIA, HUNGARY, IRELAND, INDIA, ICELAND, JAPAN, KENYA, MACEDONIA, MALTA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, POLAND, ROMANIA, RUSSIA, SWEDEN, SLOVENIA, UNITED REPUBLIC OF TANZANIA, and SOUTH AFRICA. |
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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