Events

Recall of HemoCue Glucose 201 Microcuvettes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69663
  • Event Risk Class
    Class 2
  • Event Number
    Z-0873-2015
  • Event Initiated Date
    2014-10-20
  • Event Date Posted
    2014-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131292
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Glucose oxidase, glucose - Product Code CGA
  • Reason
    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.
  • 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.

Device

HemoCue Glucose 201 Microcuvettes
  • Model / Serial
    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
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA